← Back to catalogue

VarseoSmile Crown plus

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K201668

by BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Identity

Trade Name
VarseoSmile Crown plus FDA UDI
Generic Name
Custom-made dental crown, polymer FDA UDI
Model / Reference
41109US FDA UDI

Identifiers

Catalog Number
41109US FDA UDI
Primary DI / UDI-DI
EBGO41109US1 FDA UDI
510(k) Number
K201668 FDA 510(k)FDA UDI
FDA Product Code
EBF FDA 510(k)FDA UDI
GMDN Term
Custom-made dental crown, polymer FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)FDA UDI
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

VarseoSmile Crown plus by BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
FDA Applicant
Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG

Sources (2)

  • FDA 510(k) K201668 24 fields · synced Jun 18, 2026
  • FDA UDI 508422a9-9b26-411a-bb3e-2027d8587196 36 fields · synced May 27, 2026