Elos Accurate® Hybrid Base™ Non-Engaging
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Elos Accurate® Hybrid Base™ Non-Engaging EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Hybrid Base Non-Engaging EUDAMEDThe Hybrid Base coping is intended for dental prosthetic restorations. The Hybrid Base coping is used as an interface between a dental abutment and a zirconia superstructure and will be attached to the abutment using the included prosthetic screw and attached to the zirconia superstructure by cementing. FDA UDI
- Model / Reference
- HBN-MUA45-1 EUDAMEDFDA UDIHBN-ATU45-1 FDA UDI
- Description
- The Hybrid Base coping is intended for dental prosthetic restorations. The Hybrid Base coping is used as an interface between a dental abutment and a zirconia superstructure and will be attached to the abutment using the included prosthetic screw and attached to the zirconia superstructure by cementing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05712821001160 EUDAMEDFDA UDI05712821001092 FDA UDI
- Basic UDI-DI
- 5712821011001UD EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
Elos Accurate® Hybrid Base™ Non-Engaging by Elos Medtech Pinol A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Elos Medtech Pinol A/S
Sources (3)
- FDA UDI 3c5a2fa5-6364-4766-860e-edc0ef436dbb 33 fields · synced Jul 22, 2026
- FDA UDI b9a86191-a38c-4d28-908c-3a7e0055c662 33 fields · synced May 30, 2026
- EUDAMED d8f1dee5-a7b0-4679-8bf9-6df5ac569e98 61 fields · synced Jul 22, 2026