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ZZ BASE S-S-WMSM-L12 3.3 (White Metal Scanmarker L12 with Screw)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ZZ BASE S-S-WMSM-L12 3.3 (White Metal Scanmarker L12 with Screw) FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Compatible with SIC invent SICace implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw FDA UDI
- Model / Reference
- ZBED1231L12 FDA UDI
- Description
- Compatible with SIC invent SICace implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800ZBED1231L12 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 S-S-WMSM-L12 3.3 (White Metal Scanmarker L12 with Screw) by Zirkonzahn GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, reusable.
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- 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 |
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Manufacturer
- Manufacturer
- Zirkonzahn GmbH
Sources (1)
- FDA UDI 83a7daca-26cd-4029-a032-aacdd0849942 34 fields · synced May 29, 2026