Identity
- Trade Name
- Elos Accurate Hybrid Base Engaging FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base. FDA UDI
- Model / Reference
- HBE-SBX45-1 FDA UDI
- Description
- The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base. FDA UDI
Identifiers
- Catalog Number
- HBE-SBX45-1 FDA UDI
- Primary DI / UDI-DI
- 05712821011213 FDA UDI
- 510(k) Number
- K241722 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Elos Accurate Hybrid Base Engaging by Elos Medtech Pinol A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K241722 also covers:
- Abutment Blank — Elos Medtech Pinol A/S
- Abutment Blank — Elos Medtech Pinol A/S
- Abutment Blank — Elos Medtech Pinol A/S
- CORiTEC Prosthetic Screw — Elos Medtech Pinol A/S
- CORiTEC Prosthetic Screw — Elos Medtech Pinol A/S
- CORiTEC preMill — Elos Medtech Pinol A/S
- CORiTEC preMill — 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 Pre-Milled Blank — Elos Medtech Pinol A/S
- Elos Accurate Pre-Milled Blank — 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 873d32e6-10fa-46cc-8d10-a7ae9bb0c354 35 fields · synced May 30, 2026