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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
The OVC Accessory Kit is a convenience kit for clinicians containing a procedural aids. FDA UDI
Model / Reference
OVC Accessory Kit - no Tooth Model US FDA UDI
Description
The OVC Accessory Kit is a convenience kit for clinicians containing a procedural aids. FDA UDI

Identifiers

Primary DI / UDI-DI
09421031790004 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

Yes

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 31fd4e21-439c-41f1-a37e-803d956e57a1 37 fields · synced May 30, 2026