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Lining Cement

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name
LINING CEMENT FDA UDI
Generic Name
Dental cavity liner FDA UDI
Device Name
LINING CEMENT 1-1 Pack (1 x 15 g powder, 1 x 15 g liquid, 1 x scoop, 1 x mixing pad) FDA UDI
Model / Reference
000109 FDA UDI
Description
LINING CEMENT 1-1 Pack (1 x 15 g powder, 1 x 15 g liquid, 1 x scoop, 1 x mixing pad) FDA UDI

Identifiers

Catalog Number
000109 FDA UDI
Primary DI / UDI-DI
D0470001091 FDA UDI
510(k) Number
K851468 FDA UDI
FDA Product Code
EMA FDA UDI
GMDN Term
Dental cavity liner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3275 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Dental cavity liner

Lining Cement by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental cavity liner.

Cleared under the same submission

K851468 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gc America Inc.

Sources (1)

  • FDA UDI f7c860e8-d58a-4242-aaab-c90534f58f80 37 fields · synced May 29, 2026