Identity
- Trade Name
- AVINENT FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Scan Abutment Genesis Ø3,5 CORE3D FDA UDI
- Model / Reference
- 4805 FDA UDI
- Description
- Scan Abutment Genesis Ø3,5 CORE3D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435452017306 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, reusable
Avinent by Avinent Implant System S.L.U. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, reusable.
- Snappy™ — Nobel Biocare AG · Class I
- X-Nav FastMap Scan Body — Elos Medtech Pinol A/S · Class I
- MEDENTiKA — Medentika GmbH · Class I
- ZZ BASE NB-R-WMSM-L12 5.0 (White Metal Scanmarker L12 with Screw) — Zirkonzahn GmbH · Class I
- ZZ BASE S-S-WMSM-L12 3.3 (White Metal Scanmarker L12 with Screw) — Zirkonzahn GmbH · Class I
- ZZ BASE DO-B-ICSC NC (Impression coping Screw) — Zirkonzahn GmbH · Class I
- Diamodent — Diamodent · Class II
- DS Implants — Dentsply Implants Manufacturing GmbH · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avinent Implant System S.L.U.
Sources (1)
- FDA UDI e8c9c4ba-a034-4bf3-ab85-31d8c30be47c 33 fields · synced May 30, 2026