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Fuji II

by Gc America Inc.

510(k) K980682

Fuji II is a Class II device made by Gc America Inc., cleared under FDA 510(k) K980682 on 3 Apr 1998, 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

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980682 Date3 Apr 1998ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EMA
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3275
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K980682

22 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 K980682
UDI-DISize and differences
GC Fuji II LC® 000114
Gc America Inc.
000114 / 000114D0470001141
Single use: yes
On the market
GC Fuji II LC® 000114
Gc America Inc.
000114 / 00011414548161329408
Single use: yes
On the market
GC Fuji II LC® 000115
Gc America Inc.
000115 / 00011514548161329415
Single use: yes
On the market
GC Fuji II LC® 000115
Gc America Inc.
000115 / 000115D0470001151
Single use: yes
On the market
GC Fuji II LC® 000117
Gc America Inc.
000117 / 000117D0470001171
Single use: yes
On the market
GC Fuji II LC® 000117
Gc America Inc.
000117 / 00011714548161329422
Single use: yes
On the market
GC Fuji II® 000095
Gc America Inc.
000095 / 00009514548161293716
Weight 15 g
Single use: no
On the market
GC Fuji II® 000095
Gc America Inc.
000095 / 000095D0470000951
Weight 15 g
Single use: no
On the market
GC Fuji II® 000096
Gc America Inc.
000096 / 000096D0470000961
Weight 15 g
Single use: no
On the market
GC Fuji II® 000096
Gc America Inc.
000096 / 00009614548161282925
Weight 15 g
Single use: no
On the market
GC Fuji II® 000097
Gc America Inc.
000097 / 000097D0470000971
Weight 15 g
Single use: no
On the market
GC Fuji II® 000097
Gc America Inc.
000097 / 00009714548161293754
Weight 15 g
Single use: no
On the market
GC Fuji II® 000100
Gc America Inc.
000100 / 00010014548161283052
Total Volume 8 mL
Single use: no
On the market
GC Fuji II® 000100
Gc America Inc.
000100 / 000100D0470001001
Total Volume 8 mL
Single use: no
On the market
GC Fuji II® 000101
Gc America Inc.
000101 / 00010114548161293976
Single use: no
On the market
GC Fuji II® 000101
Gc America Inc.
000101 / 000101D0470001011
Single use: no
On the market
GC Fuji II® 000102
Gc America Inc.
000102 / 000102D0470001021
Single use: no
On the market
GC Fuji II® 000102
Gc America Inc.
000102 / 00010214548161282512
Single use: no
On the market
GC Fuji II® 000103
Gc America Inc.
000103 / 00010314548161294089
Single use: no
On the market
GC Fuji II® 000103
Gc America Inc.
000103 / 000103D0470001031
Single use: no
On the market
GC Fuji VARNISH™ 000026
Gc America Inc.
000026 / 000026D0470000261
Total Volume 10 mL
Single use: no
On the market
GC Fuji VARNISH™ 000026
Gc America Inc.
000026 / 00002614548161282635
Total Volume 10 mL
Single use: no
On the market

Similar devices

Other devices filed under FDA product code EMA (Cement, Dental).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →