Identity
- Trade Name
- Creation Willi Geller FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- Creapearl A2 V61 FDA UDI
- Model / Reference
- A200100V61 FDA UDI
- Description
- Creapearl A2 V61 FDA UDI
Identifiers
- Catalog Number
- A200100V61 FDA UDI
- Primary DI / UDI-DI
- ECWGA200100V611 FDA UDI
- 510(k) Number
- K010160 FDA UDI
- FDA Product Code
- ELM FDA UDI
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3590 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Resin artificial teeth
Creation Willi Geller by KLEMA Dentalprodukte GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K010160 also covers:
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
- Creation Willi Geller — KLEMA Dentalprodukte GmbH
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KLEMA Dentalprodukte GmbH
Sources (1)
- FDA UDI 99825504-2381-44ce-b74f-4e09e9df0ebc 36 fields · synced Jun 8, 2026