Singapore HSA registration DE0507428

ALTATEC SCREW-LINE Instruments

Singapore·CLASS B·ALTATEC GmbH·Registered October 28, 2022

Device classification

Device Class: CLASS B
Medical Speciality Area: Dental

Registration information

Registration Number: DE0507428
Registration Date: October 28, 2022
Change Notification Approval Date: January 12, 2024
Retention Due Date: October 27, 2025

Product description

Drills and its depth stops: Drills are intended for the preparation of the implant bed for the placement of an endosseous implant in the maxilla and/or mandible. Instruments with ISO-shaft (Drivers for implants): (J5300.003x) Drivers are used to insert the implant during surgery. instruments with ISO-shaft (Screw drivers for prosthetics): (J5317.050x) Screw drivers are used for the fixation of prosthetic components. Drill extensions: Drill extensions are used to extend the drilling axis in case of high neighbouring teeth. Surgery Set: The Surgery sets is intended to provide the instruments necessary for the preparation of the implant bed for the placement of an endosseous implant in the maxilla and/or mandible.

Product Owner

Name: ALTATEC GmbH
Short Name: ALTATEC GmbH
Address: Maybachstr. 5, 71299 Wimsheim, GERMANY

Registrant

Name: BIOHORIZONS CAMLOG PTE LTD
Address: 9 RAFFLES PLACE, REPUBLIC PLAZA, #26-01, SINGAPORE 048619

Importer

Name: BIOHORIZONS CAMLOG PTE LTD IMPLANTATE PTE. LTD.
Address: 9 RAFFLES PLACE, REPUBLIC PLAZA, #26-01, SINGAPORE 048619 302 ANG MO KIO AVENUE 3, #01-1836, SINGAPORE 560302

Model information

Model Name(s): Drill extension, ISO shaft Depth stop, SCREW-LINE, f. pilot drill and pre-drill L 7.0 mm Depth stop SCREW-LINE, f. pilot drills and pre-drills L 9.0 mm Depth stop SCREW-LINE, f. pilot drills and pre-drills L 11.0 mm Depth stop SCREW-LINE, f. pilot drills and pre-drills L 13.0 mm Depth stop for form drills SCREW-LINE Ø 3.3 mm Depth stop for form drills SCREW-LINE Ø 3.8 mm Depth stop for form drills SCREW-LINE Ø 4.3 mm Depth stop for form drills SCREW-LINE Ø 5.0 mm Depth stop for form drills SCREW-LINE Ø 6.0 mm Form drill SCREW-LINE, Ø 3.3 mm, L 9.0 mm Form drill SCREW-LINE, Ø 3.3 mm, L 11.0 mm Form drill SCREW-LINE, Ø 3.3 mm, L 13.0 mm Form drill SCREW-LINE, Ø 3.3 mm, L 16.0 mm Form drill SCREW-LINE, Ø 3.8 mm, L 7.0 mm Form drill SCREW-LINE, Ø 3.8 mm, L 9.0 mm Form drill SCREW-LINE, Ø 3.8 mm, L 11.0 mm Form drill SCREW-LINE, Ø 3.8 mm, L 13.0 mm Form drill SCREW-LINE, Ø 3.8 mm, L 16.0 mm Form drill SCREW-LINE, Ø 4.3 mm, L 7.0 mm Form drill SCREW-LINE, Ø 4.3 mm, L 9.0 mm Form drill SCREW-LINE, Ø 4.3 mm, L 11.0 mm Form drill SCREW-LINE, Ø 4.3 mm, L 13.0 mm Form drill SCREW-LINE, Ø 4.3 mm, L 16.0 mm Form drill SCREW-LINE, Ø 5.0 mm, L 7.0 mm Form drill SCREW-LINE, Ø 5.0 mm, L 9.0 mm Form drill SCREW-LINE, Ø 5.0 mm, L 11.0 mm Form drill SCREW-LINE, Ø 5.0 mm, L 13.0 mm Form drill SCREW-LINE, Ø 5.0 mm, L 16.0 mm Form drill SCREW-LINE, Ø 6.0 mm, L 9.0 mm Form drill SCREW-LINE, Ø 6.0 mm, L 11.0 mm Form drill SCREW-LINE, Ø 6.0 mm, L 13.0 mm Form drill SCREW-LINE, Ø 6.0 mm, L 16.0 mm Driver, short, f. scr. Impl., ISO-shaft Driver, long, f. scr.impl., ISO-shaft Driver, short, f.scr.impl., ISO-shaft without hex Driver, long, f.scr.impl., ISO-shaft without hex Surgery set SCREW-LINE Screwdriver hex, long, ISO shaft Screwdriver hex, short, ISO shaft
Model Identifier(s): J5002.0006 J5015.0007 J5015.0009 J5015.0011 J5015.0013 J5015.3300 J5015.3800 J5015.4300 J5015.5000 J5015.6000 J5062.3309 J5062.3311 J5062.3313 J5062.3316 J5062.3807 J5062.3809 J5062.3811 J5062.3813 J5062.3816 J5062.4307 J5062.4309 J5062.4311 J5062.4313 J5062.4316 J5062.5007 J5062.5009 J5062.5011 J5062.5013 J5062.5016 J5062.6009 J5062.6011 J5062.6013 J5062.6016 J5300.0034 J5300.0035 J5300.0036 J5300.0037 J5300.0063 J5317.0503 J5317.0504

About this record

Access comprehensive regulatory information for ALTATEC SCREW-LINE Instruments in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507428 and owned by ALTATEC GmbH. The device was registered on October 28, 2022.

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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