Singapore HSA registration DE0500414

Pentron Dental Restorative Materials

Singapore·CLASS B·Pentron Clinical·Registered April 06, 2016

Device classification

Device Class: CLASS B
Medical Speciality Area: Dental
HSA Product Code: HSAMDB00103
HS Code: 30064010

Registration information

Registration Number: DE0500414
Registration Date: April 06, 2016
Change Notification Approval Date: August 16, 2024
Retention Due Date: April 05, 2026

Product description

A substance intended to fill dental cavities, seal pits and fissures, restore damaged dental tissues, or for inlays, onlays and veneering. It may include accessories that are used specifically with the materials. It does not include obturation of root canal.

Product Owner

Name: Pentron Clinical
Short Name: Pentron Clinical
Address: 1717 West Collins Avenue, Orange, California 92867, UNITED STATES

Registrant

Name: EHC SUPPLY
Address: 7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591

Importer

Name: EHC COMMERCIAL SINGAPORE PTE. LTD. EHC SUPPLY
Address: 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905

Model information

Model Name(s): Flow-It ALC Flowable Composite A1 Flow-It ALC Flowable Composite A2 Flow-It ALC Flowable Composite A3 Flow-It ALC Flowable Composite B2 Flow-It ALC Flowable Composite B3 Flow-It ALC Flowable Composite C2 Flow-It ALC Flowable Composite C3 Flow-It ALC Flowable Composite Clear Flow-It ALC Flowable Composite Univ. Opaque Flow-It ALC Flowable Composite A3.5 Flow-It ALC Flowable Composite A4 Flow-It ALC Flowable Composite B1 Flow-It ALC Flowable Composite C1 Flow-It ALC Flowable Composite B5 Flow-It ALC Flowable Composite C4 Flow-It ALC Flowable Composite D2 Flow-It ALC Flowable Composite D3 Flow-It ALC Flowable Composite D4 Flow-It ALC Flowable Composite Pedo Lgt. Flow-It ALC Flowable Composite Pedo XLgt. Flow-It ALC Flowable Composite Value Pack A1 Flow-It ALC Flowable Composite Value Pack A2 Flow-It ALC Flowable Composite Value Pack A3 Flow-It ALC Flowable Composite Value Pack B2 Flow-It ALC Flowable Composite Value Pack B3 Flow-It ALC Flowable Composite Value Pack C2 Flow-It ALC Flowable Composite Value Pack C3 Flow-It ALC Flowable Composite Value Pack Clear Flow-It ALC Flowable Composite Value Pack Wht Op Flow-It ALC Flowable Composite Value Pack A3.5 Flow-It ALC Flowable Composite Value Pack A4 Flow-It ALC Flowable Composite Value Pack B1 Flow-It ALC Flowable Composite Value Pack C1 Flow-It ALC Flowable Composite Value Pack B5 Flow-It ALC Flowable Composite Value Pack C4 Flow-It ALC Flowable Composite Value Pack D2 Flow-It ALC Flowable Composite Value Pack D3 Flow-It ALC Flowable Composite Value Pack D4 Flow-It ALC Flowable Composite Value Pack Pedo Lgt. Flow-It ALC Flowable Composite Value Pack Pedo XLgt. Flow-It ALC Flowable Composite Value Pack A0 Flow-It ALC Flowable Composite Value Pack B0 Flow-It ALC Flowable Composite Value Pack Incisal Flow-It ALC Flowable Composite Value Pack Univ. Opaque Flow-It ALC Flowable Composite Intro Kit Flow-It ALC Flowable Composite A0 Flow-It ALC Flowable Composite B0 Flow-It ALC Flowable Composite Incisal Flow-It ALC Flowable Composite Wht Op Alert Condensable Composite 10 - .25gm Single Doses Refill A2 Alert Condensable Composite 10 - .25gm Single Doses Refill A3 Alert Condensable Composite 10 - .25gm Single Doses Refill A3.5 Alert Condensable Composite 10 - .25gm Single Doses Refill B1 Alert Condensable Composite 10 - .25gm Single Doses Refill C2 Alert Condensable Composite 1 - 1.9ml/4gm Syringe A2 Alert Condensable Composite 1 - 1.9ml/4gm Syringe A3 Alert Condensable Composite 1 - 1.9ml/4gm Syringe A3.5 Alert Condensable Composite 1 - 1.9ml/4gm Syringe B1 Alert Condensable Composite 1 - 1.9ml/4gm Syringe C2 Fusio Self-Adhesive Flowable Composite Fusio Self-Adhesive Flowable Composite Fusio Self-Adhesive Flowable Composite Fusio Self-Adhesive Flowable Composite 19 G Bent Needle Tips Build-It FR Core Material Kit Build-It FR Core Material 25ml A2 Build-It FR Core Material 25ml Gold Build-It FR Core Material 25ml Blue Build-It FR Core Material 25ml OP WHT Build-It FR Core Material 25ml A3 25ml 1:1 Dispenser Gun 48 - Intra Oral Tips Built-It FR Cartridge 48 - Ex-Waste Saver Tips Built-It FR Core Build-Up Material Cartridge Build-It FR Core Material Mini-Mix Syringe Kit Build-It FR Core Material Mini-Mix Syringe Refill Kit A2 Build-It FR Core Material Mini-Mix Syringe Refill Kit A3 Build-It FR Core Material Mini-Mix Syringe Refill Kit Gold Build-It FR Core Material Mini-Mix Syringe Refill Kit Blue Build-It FR Core Material Mini-Mix Syringe Refill Kit OP WHT Build-It FR Core Material Syringe Refill, A2 Build-It FR Core Material Syringe Refill, A3 Build-It FR Core Material Syringe Refill, Gold Build-It FR Core Material Syringe Refill, Blue Build-It FR Core Material Syringe Refill, Opaque White 48 - Mixing Tips/Intra Oral Tips Built-It FR Cartridge Mini-Mix Core Build-Up Material Syringe 100 - Mixing Tips/Intra Oral Tips Built-It FR Cartridge Mini-Mix Core Build-Up Material Syringe Build-It Light Cure Core Material Syringe Kit Translucent Build-It Light Cure Core Material Single Dose Kit Translucent Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe A1 Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe A2 Artise Nano CompositeSyringe Refills 1 - 2ml/4gm Syringe A3 Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe A3.5 Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe B1 Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe B2 Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe B3 Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe C1 Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe C2 Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe C3 Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe A Opaque Artise Nano Composite Syringe Refills 1 - 2ml/4gm Syringe Bleach Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses A1 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses A2 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses A3 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses A3.5 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses B1 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses B2 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses B3 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses C1 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses C2 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses C3 Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses A Opaque Artise Nano Composite Single-Dose Refills 10 - .25gm Single Doses Bleach Simile Universal Composite 10 Shade Syringe Kit Simile Universal Composite Syringe A1 Simile Universal Composite Syringe A2 Simile Universal Composite Syringe A3 Simile Universal Composite Syringe A3.5 Simile Universal Composite Syringe B1 Simile Universal Composite Syringe B2 Simile Universal Composite Syringe B3 Simile Universal Composite Syringe C2 Simile Universal Composite Syringe Opaque Universal Simile Universal Composite Syringe Clear Incisal Simile Universal Composite Syringe C3 Simile Universal Composite Syringe C1 Simile Universal Composite Syringe A4 Simile Universal Composite Syringe B4 Simile Universal Composite Syringe C4 Simile Universal Composite Syringe D2 Simile Universal Composite Syringe D3 Simile Universal Composite Syringe d4 Simile Universal Composite Syringe A0 Simile Universal Composite Syringe B0 Simile Universal Composite Single Dose A1 Simile Universal Composite Single Dose A2 Simile Universal Composite Single Dose A3 Simile Universal Composite Single Dose A3.5 Simile Universal Composite Single Dose B1 Simile Universal Composite Single Dose B2 Simile Universal Composite Single Dose B3 Simile Universal Composite Single Dose C1 Simile Universal Composite Single Dose C3 Simile Universal Composite Single Dose C2 Simile Universal Composite Single Dose Universal Opaque Simile Universal Composite Single Dose Clear Incisal Simile Universal Composite Single Dose A4 Simile Universal Composite Single Dose B4 Simile Universal Composite Single Dose C4 Simile Universal Composite Single Dose D2 Simile Universal Composite Single Dose D3 Simile Universal Composite Single Dose d4 Simile Universal Composite Single Dose A0 Simile Universal Composite Single Dose B0 Simile Universal Composite 10 Shade Single Dose Kit TempSpan Temporary C&B Material A0 TempSpan Temporary C&B Material A1 TempSpan Temporary C&B Material A2 TempSpan Temporary C&B Material A3 TempSpan Temporary C&B Material A3.5 TempSpan Temporary C&B Material B1 TempSpan Temporary C&B Material C2 Mixing Tips: 30 - 1: 1 Mixing Tips TempSpan Crown & Bridge Cartridge Mixing Tips: 100 - 1: 1 Mixing Tips TempSpan Crown & Bridge Cartridge Single Dose Dispenser Gun 1:1 Dispenser Gun 50ml 1:1 Dispenser Gun 20G Bent Needle Tips 20G Bent Needle Tips
Model Identifier(s): N11A N11B N11C N11D N11E N11F N11G N11H N11I N11J N11K N11L N11M N11N N11O N11P N11Q N11R N11U N11V N11VA N11VB N11VC N11VD N11VE N11VF N11VG N11VH N11VI N11VJ N11VK N11VL N11VM N11VN N11VO N11VP N11VQ N11VR N11VU N11VV N11VXA N11VXB N11VXC N11VXD N11WA N11XA N11XB N11XC N11XD N15HA N15HB N15HC N15HD N15HE N15SA N15SB N15SC N15SD N15SE N21SA N21SB N21SC N21SD N28NT N32 N32AA N32AB N32AC N32AD N32AE N32B N32D N32E N32F N32FA N32FB N32FC N32FD N32FE N32FS N32FSA N32FSB N32FSC N32FSD N32GA N32GB N32T N32U N36AA N36AB N36AC N36AD N36AF N36AG N36AH N36AJ N36AK N36AL N36AOA N36AQ N36BA N36BB N36BC N36BD N36BF N36BG N36BH N36BJ N36BK N36BL N36BOA N36BQ N56A N56AA N56AB N56AC N56AD N56AE N56AF N56AG N56AH N56AI N56AJ N56AK N56AL N56AN N56AO N56AP N56AQ N56AR N56AS N56AT N56AU N56BA N56BB N56BC N56BD N56BE N56BF N56BG N56BH N56BI N56BJ N56BK N56BL N56BM N56BN N56BO N56BP N56BQ N56BR N56BS N56BT N56C N69AA N69AB N69AC N69AD N69AE N69AF N69AG N69AH N69AI N75A N75S Q19 T26A T26C

About this record

Access comprehensive regulatory information for Pentron Dental Restorative Materials in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500414 and owned by Pentron Clinical. The device was registered on April 06, 2016.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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