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OVC™ One Visit Crown

FDA UDI

Class II (US FDA UDI)

by Rhondium, Ltd.

Identity

Trade Name
OVC™ One Visit Crown FDA UDI
Generic Name
Preformed dental crown, permanent FDA UDI
Device Name
Package contains an OVC for tooth number 20 or 21, in shade A2 and size XL (extra large), 4 x OVC wedges, a selector key and an OVC Replica FDA UDI
Model / Reference
OVC 20-21 XL A2 FDA UDI
Description
Package contains an OVC for tooth number 20 or 21, in shade A2 and size XL (extra large), 4 x OVC wedges, a selector key and an OVC Replica FDA UDI

Identifiers

Primary DI / UDI-DI
09421031790370 FDA UDI
510(k) Number
K143694 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Preformed dental crown, permanent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
Not 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

OVC™ One Visit Crown by Rhondium, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K143694 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rhondium, Ltd.

Sources (1)

  • FDA UDI 721158ea-7397-4beb-8c82-af7ea8993e5a 38 fields · synced Jun 8, 2026