Identity
- Trade Name
- Elos Accurate® Hexalobular Prosthetic Screw FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface. FDA UDI
- Model / Reference
- AS-HETM1610A-1 FDA UDI
- Description
- The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface. FDA UDI
Identifiers
- Catalog Number
- AS-HETM1610A-1 FDA UDI
- Primary DI / UDI-DI
- 05712821010520 FDA UDI
- 510(k) Number
- K230317 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental prosthesis/implant abutment screw
Elos Accurate® Hexalobular Prosthetic Screw by Elos Medtech Pinol A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- Implant Prosthetics — PREAT Corporation · Class II
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
Cleared under the same submission
K230317 also covers:
- Elos Accurate Hybrid Base Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base H Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base H Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base H Engaging — Elos Medtech Pinol A/S
- Elos Accurate Hybrid Base H Engaging — Elos Medtech Pinol A/S
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Elos Medtech Pinol A/S
Sources (1)
- FDA UDI 246e2f02-a3f9-4721-aa90-7b6541efe8bb 35 fields · synced May 31, 2026