Identity
- Trade Name
- VarseoSmile Crown plus FDA UDI
- Generic Name
- Custom-made dental crown, polymer FDA UDI
- Model / Reference
- 41107US FDA UDI
Identifiers
- Catalog Number
- 41107US FDA UDI
- Primary DI / UDI-DI
- EBGO41107US1 FDA UDI
- 510(k) Number
- K201668 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Custom-made dental crown, polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Custom-made dental crown, polymer
VarseoSmile Crown plus by BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made dental crown, polymer.
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- Flexcera™ Smile Ultra+ Bleach — Envisiontec GmbH · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
Cleared under the same submission
K201668 also covers:
- Permanent Crown A2 — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- Permanent Crown A3 — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- Permanent Crown B1 — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- Permanent Crown C2 — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- SprintRay Crown — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- SprintRay Crown — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- SprintRay Crown — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- SprintRay Crown — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- SprintRay Crown — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- SprintRay Crown — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- SprintRay Crown — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
- SprintRay Crown — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
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 |
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Manufacturer
- Manufacturer
- BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
Sources (1)
- FDA UDI bee3ad60-c83d-48a7-99e2-5012bf224415 36 fields · synced Jun 8, 2026