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Fuji Duet

by Gc America Inc.

510(k) K946100

Fuji Duet is a Class II device made by Gc America Inc., cleared under FDA 510(k) K946100 on 20 Jan 1995, 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 NumberK946100 Date20 Jan 1995ClearedStatusActive

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  • Withdrawn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 K946100

14 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 K946100
UDI-DISize and differences
GC Fuji PLUS® 000221
Gc America Inc.
000221 / 00022114548161283083
Weight 7 g
Single use: no
On the market
GC Fuji PLUS® 000221
Gc America Inc.
000221 / 000221D0470002211
Weight 7 g
Single use: no
On the market
GC Fuji PLUS® 425030
Gc America Inc.
425030 / 42503010386040008839
Single use: yes
On the market
GC Fuji PLUS® 425030
Gc America Inc.
425030 / 425030D6584250301
Single use: yes
On the market
GC Fuji PLUS® 425035
Gc America Inc.
425035 / 42503510386040008846
Single use: yes
On the market
GC Fuji PLUS® 425035
Gc America Inc.
425035 / 425035D6584250351
Single use: yes
On the market
GC Fuji PLUS® 431011
Gc America Inc.
431011 / 43101110386040009133
Single use: no
On the market
GC Fuji PLUS® 431011
Gc America Inc.
431011 / 431011D6584310111
Single use: no
On the market
GC Fuji PLUS® 431012
Gc America Inc.
431012 / 431012D6584310121
Single use: no
On the market
GC Fuji PLUS® 431012
Gc America Inc.
431012 / 43101210386040009140
Single use: no
On the market
GC Fuji PLUS® 431091
Gc America Inc.
431091 / 431091D6584310911
Single use: no
On the market
GC Fuji PLUS® 431091
Gc America Inc.
431091 / 43109110386040009157
Single use: no
On the market
GC Fuji PLUS® 431101
Gc America Inc.
431101 / 431101D6584311011
Single use: no
On the market
GC Fuji PLUS® 431101
Gc America Inc.
431101 / 43110110386040009164
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. →