Identity
- Trade Name
- ZZ BASE ME-AO-ICSC R - W (Impression coping Screw) FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Compatible with Megagen AnyOne implants Consisting of: 1x Screw for impression copings FDA UDI
- Model / Reference
- BSFE10302 FDA UDI
- Description
- Compatible with Megagen AnyOne implants Consisting of: 1x Screw for impression copings FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800BSFE10302 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, reusable
ZZ BASE ME-AO-ICSC R - W (Impression coping Screw) by Zirkonzahn GmbH — 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
- Diamodent — Diamodent · Class II
- DS Implants — Dentsply Implants Manufacturing GmbH · Class I
- DTI IMPLANT SISTEMLERI — Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Elos Accurate® Scan Body 22 — Elos Medtech Pinol A/S · 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
- Zirkonzahn GmbH
Sources (1)
- FDA UDI d6829806-d553-4a71-a4b5-13fced689919 34 fields · synced May 30, 2026