Gradia®

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name: GRADIA® FDA UDI
Generic Name: Light-cured dental restorative composite resin FDA UDI
Device Name: GRADIA® gum Starter Package Contains: Two opaques (2.4 mL syringes), 4 shades (2.9 mL syringes), 1 translucent (2.4 mL syringe), 1 disposable palette, 1 light protective cover, 1 mixing pad, #7 brush, 1 Shade Guide Kit and 1 Color Chart. FDA UDI
Model / Reference: 001889 FDA UDI
Description: GRADIA® gum Starter Package Contains: Two opaques (2.4 mL syringes), 4 shades (2.9 mL syringes), 1 translucent (2.4 mL syringe), 1 disposable palette, 1 light protective cover, 1 mixing pad, #7 brush, 1 Shade Guide Kit and 1 Color Chart. FDA UDI

Identifiers

Catalog Number: 001889 FDA UDI
Primary DI / UDI-DI: D0470018891 FDA UDI
510(k) Number: K001518 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Light-cured dental restorative composite resin 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Light-cured dental restorative composite resin

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

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Cleared under the same submission

K001518 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Gc America Inc.

Sources (1)

FDA UDI c83de721-b596-43ed-8624-9743efd93578 36 fields · synced May 30, 2026