Identity
- Trade Name
- SET ZZ BASE C-J-WSM 4.3 FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- SET ZZ BASE C-J-WSM 4.3 (White Scanmarker and screw). The ZZ BASE WSM (WHITE SCANMARKER) allows the user to record the implant position and inclination in the patient’s mouth or on the model. FDA UDI
- Model / Reference
- ZBCD2033 FDA UDI
- Description
- SET ZZ BASE C-J-WSM 4.3 (White Scanmarker and screw). The ZZ BASE WSM (WHITE SCANMARKER) allows the user to record the implant position and inclination in the patient’s mouth or on the model. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800ZBCD2033 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant abutment analog, intraoral-scanning, single-use 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
Yes
FDA UDI
Implantable
No
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 abutment analog, intraoral-scanning, single-use
Set Zz Base C-J-Wsm 4.3 by Zirkonzahn GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant abutment analog, intraoral-scanning, single-use.
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- Azure — TERRATS MEDICAL SL. · Class I
- Azure — TERRATS MEDICAL SL. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · 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 1d16d8b3-083a-45b4-bc3f-6453dabe18b6 33 fields · synced Jun 8, 2026