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GC Initial™

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name
GC Initial™ FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
GC Initial™ INcisio MC&LF Stain, 3g FDA UDI
Model / Reference
876030 FDA UDI
Description
GC Initial™ INcisio MC&LF Stain, 3g FDA UDI

Identifiers

Catalog Number
876030 FDA UDI
Primary DI / UDI-DI
J0228760301 FDA UDI
510(k) Number
K040567 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

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

Dimensions & Sizes

Size
Weight — 3 Gram FDA UDI

GC Initial™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K040567 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 c6d8f5f2-d09c-4e87-9ea8-8b4bef223249 39 fields · synced May 31, 2026