Gradia Direct

510(k) K023814

Gradia Direct is a medical device (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Gc America Inc., cleared under FDA 510(k) K023814 on 30 Jan 2003, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K023814↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK023814	Date30 Jan 2003Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K023814

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K023814
FDA product code: EBF
FDA applicant: GC America, Inc.

Device class: Class II
Regulation: 21 CFR Part 872.3690
Advisory committee: Dental
FDA decision: SESE Substantially Equivalent

Devices cleared under K023814

113 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K023814
		UDI-DI	Size and differences
GRADIA® 001970 Gc America Inc.	001970 / 001970	D0470019701	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001971 Gc America Inc.	001971 / 001971	D0470019711	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001971 Gc America Inc.	001971 / 001971	14548161073530	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001972 Gc America Inc.	001972 / 001972	14548161073547	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001975 Gc America Inc.	001975 / 001975	14548161073578	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001977 Gc America Inc.	001977 / 001977	14548161073592	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001977 Gc America Inc.	001977 / 001977	D0470019771	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001978 Gc America Inc.	001978 / 001978	14548161073608	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001978 Gc America Inc.	001978 / 001978	D0470019781	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001980 Gc America Inc.	001980 / 001980	14548161073622	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001980 Gc America Inc.	001980 / 001980	D0470019801	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001981 Gc America Inc.	001981 / 001981	D0470019811	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001981 Gc America Inc.	001981 / 001981	14548161073639	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001982 Gc America Inc.	001982 / 001982	14548161073646	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001983 Gc America Inc.	001983 / 001983	14548161073653	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001984 Gc America Inc.	001984 / 001984	D0470019841	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001984 Gc America Inc.	001984 / 001984	14548161073660	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001986 Gc America Inc.	001986 / 001986	14548161073684	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001988 Gc America Inc.	001988 / 001988	D0470019881	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 001989 Gc America Inc.	001989 / 001989	14548161073714	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 001990 Gc America Inc.	001990 / 001990	D0470019901	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 001991 Gc America Inc.	001991 / 001991	14548161073738	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 001992 Gc America Inc.	001992 / 001992	D0470019921	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 001992 Gc America Inc.	001992 / 001992	14548161073745	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 001993 Gc America Inc.	001993 / 001993	D0470019931	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 001997 Gc America Inc.	001997 / 001997	D0470019971	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 001998 Gc America Inc.	001998 / 001998	D0470019981	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 002000 Gc America Inc.	002000 / 002000	D0470020001	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 002003 Gc America Inc.	002003 / 002003	14548161073851	Total Volume 2.7 mL Single use: no	On the market
GRADIA® 002004 Gc America Inc.	002004 / 002004	14548161073868	Total Volume 2.7 mL Single use: no	On the market
GRADIA® 002004 Gc America Inc.	002004 / 002004	D0470020041	Total Volume 2.7 mL Single use: no	On the market
GRADIA® 002008 Gc America Inc.	002008 / 002008	14548161073905	Total Volume 2.7 mL Single use: no	On the market
GRADIA® 002040 Gc America Inc.	002040 / 002040	D0470020401	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 002041 Gc America Inc.	002041 / 002041	14548161074100	Total Volume 0.16 mL Single use: yes	On the market
GRADIA® 002042 Gc America Inc.	002042 / 002042	D0470020421	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002043 Gc America Inc.	002043 / 002043	D0470020431	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002044 Gc America Inc.	002044 / 002044	D0470020441	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002044 Gc America Inc.	002044 / 002044	14548161074131	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002045 Gc America Inc.	002045 / 002045	14548161074148	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002045 Gc America Inc.	002045 / 002045	D0470020451	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002046 Gc America Inc.	002046 / 002046	D0470020461	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002046 Gc America Inc.	002046 / 002046	14548161074155	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002047 Gc America Inc.	002047 / 002047	D0470020471	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002048 Gc America Inc.	002048 / 002048	D0470020481	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002049 Gc America Inc.	002049 / 002049	14548161074186	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002049 Gc America Inc.	002049 / 002049	D0470020491	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002050 Gc America Inc.	002050 / 002050	14548161074193	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002054 Gc America Inc.	002054 / 002054	D0470020541	Total Volume 2.4 mL Single use: no	On the market
GRADIA® 002055 Gc America Inc.	002055 / 002055	D0470020551	Total Volume 2.7 mL Single use: no	On the market
GRADIA® 002274 Gc America Inc.	002274 / 002274	14548161075312	Total Volume 2.4 mL Single use: no	On the market

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Gradia Direct

Regulatory status

Coverage

Specification

Devices cleared under K023814

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