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OVC Hybrid

FDA UDI

Class II (US FDA UDI)

by Rhondium, Ltd.

Identity

Trade Name
OVC Hybrid FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
The Introduction Kit consists of a set of 10 OVC Lithium in tooth shade A2 - 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 Hybrid is packaged with 4 x OVC Wedges, a Selector Key, OVC Matrix Band and an OVC Hybrid Replica. FDA UDI
Model / Reference
Introduction Lite Kit A2 FDA UDI
Description
The Introduction Kit consists of a set of 10 OVC Lithium in tooth shade A2 - 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 Hybrid is packaged with 4 x OVC Wedges, a Selector Key, OVC Matrix Band and an OVC Hybrid Replica. FDA UDI

Identifiers

Catalog Number
81012101011 FDA UDI
Primary DI / UDI-DI
09421031791933 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 Hybrid 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 18cad786-3019-4611-ad1b-5373e965e79f 38 fields · synced May 30, 2026