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Singapore HSA registration DE0508889

Zest Anchors LOCATOR R-Tx Attachment System

Singapore flagSingapore·CLASS C·Zest Anchors, LLC·Registered January 24, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration information
Registration Number
DE0508889
Registration Date
January 24, 2024
Retention Due Date
January 23, 2026
Product description
The LOCATOR R-Tx Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla.
Product Owner
Name
Zest Anchors, LLC
Short Name
Zest Anchors, LLC
Address
2875 Loker Avenue East, Carlsbad, CA 92010, UNITED STATES
Registrant
Name
DENTSPLY SIRONA SINGAPORE PTE LTD
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
Name
DENTSPLY SIRONA SINGAPORE PTE LTD
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Model information
Model Name(s)
Abutment EV (S) 1mm Abutment EV (S) 2mm Abutment EV (S) 3mm Abutment EV (S) 4mm Abutment EV (S) 5mm Abutment EV (S) 6mm Abutment EV (M) 1mm Abutment EV (M) 2mm Abutment EV (M) 3mm Abutment EV (M) 4mm Abutment EV (M) 5mm Abutment EV (M) 6mm Abutment EV (L) 1mm Abutment EV (L) 2mm Abutment EV (L) 3mm Abutment EV (L) 4mm Abutment EV (L) 5mm Abutment EV (L) 6mm Zero Retention Insert, (4 Pack) Low Retention , (4 Pack) Medium Retention Insert, (4 Pack) High Retention Insert, (4 Pack) Limited Range Retention Inserts, Low (4 pack) Limited Range Retention Inserts, Medium (4 pack) Limited Range Retention Inserts, High (4 pack) Limited Range Retention Inserts, Processing Pack (2 pack) Processing Retention Insert (4 Pack) Denture Attachment Processing Assembly Ankylos Abutment C/ 2mm Ankylos Abutment C/ 3mm Ankylos Abutment C/ 4mm Ankylos Abutment C/ 5mm Ankylos Abutment C/ 6mm
Model Identifier(s)
68012414 68012415 68012416 68012417 68012418 68012419 68012420 68012421 68012422 68012423 68012424 68012425 68012426 68012427 68012428 68012429 68012430 68012431 68012432 68012433 68012434 68012435 68012436 68012437 68012438 68012439 68012440 68012442 68012447   68012448 68012449 68012450 68012451
About this record

Access comprehensive regulatory information for Zest Anchors LOCATOR R-Tx Attachment System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508889 and owned by Zest Anchors, LLC. The device was registered on January 24, 2024.

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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