← Back to catalogue

OVC3 Hybrid

FDA UDI

Class II (US FDA UDI)

by Rhondium, Ltd.

Identity

Trade Name
OVC3 Hybrid FDA UDI
Generic Name
Preformed dental crown, permanent FDA UDI
Device Name
Package contains an OVC Hybrid in Shade A3 for tooth number FDI 26.27 S : USA 14-15 S A3 (Small) 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band and 1 x OVC Replica FDA UDI
Model / Reference
OVC3 Hybrid FDI 26.27 S : USA 14-15 S A3 FDA UDI
Description
Package contains an OVC Hybrid in Shade A3 for tooth number FDI 26.27 S : USA 14-15 S A3 (Small) 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band and 1 x OVC Replica FDA UDI

Identifiers

Catalog Number
9421031796327 FDA UDI
Primary DI / UDI-DI
09421031796327 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
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: Preformed dental crown, permanent

OVC3 Hybrid by Rhondium, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Preformed dental crown, permanent.

Cleared under the same submission

K143694 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Rhondium, Ltd.

Sources (1)

  • FDA UDI 7401cb50-d6f8-4e76-892c-6864f4f07d0a 38 fields · synced May 30, 2026