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OVC Lithium

FDA UDI

Class II (US FDA UDI)

by Rhondium, Ltd.

Identity

Trade Name
OVC Lithium FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
The Introduction Lite Kit consists of a set of 10 OVC Lithium in tooth shade A3 - one each of OVC Lithium 4-5 S, M, 12-13 S, M, 18-19 S, M, L, 30-31 S, M, L. Each OVC Lithium is packaged with 4 x OVC Wedges, a Selector Key, OVC Matrix Band and an OVC Lithium Replica. FDA UDI
Model / Reference
Introduction Lite Kit A3 FDA UDI
Description
The Introduction Lite Kit consists of a set of 10 OVC Lithium in tooth shade A3 - one each of OVC Lithium 4-5 S, M, 12-13 S, M, 18-19 S, M, L, 30-31 S, M, L. Each OVC Lithium is packaged with 4 x OVC Wedges, a Selector Key, OVC Matrix Band and an OVC Lithium Replica. FDA UDI

Identifiers

Catalog Number
81001101021 FDA UDI
Primary DI / UDI-DI
09421031791902 FDA UDI
FDA Product Code
EIH FDA UDI
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6660 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 Lithium by Rhondium, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rhondium, Ltd.

Sources (1)

  • FDA UDI 4706deb5-dd4b-47a8-aec6-065991a8ddfd 38 fields · synced Jun 1, 2026