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Gc Fusion

by Gc America Inc.

510(k) K041398

Gc Fusion is a Class II device made by Gc America Inc., cleared under FDA 510(k) K041398 on 25 Jun 2004, 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 NumberK041398 Date25 Jun 2004ClearedStatusActive

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  • Withdrawn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
ELW
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3660
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 K041398

84 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 K041398
UDI-DISize and differences
EXAlence™ 137004
Gc America Inc.
137004 / 137004D6581370041
Total Volume 48 mL
Single use: no
On the market
EXAlence™ 137004
Gc America Inc.
137004 / 13700410386040005173
Total Volume 48 mL
Single use: no
On the market
EXAlence™ 137104
Gc America Inc.
137104 / 137104D6581371041
Single use: no
On the market
EXAlence™ 137104
Gc America Inc.
137104 / 13710410386040005302
Single use: no
On the market
EXAlence™ 137170
Gc America Inc.
137170 / 137170D6581371701
Single use: no
On the market
EXAlence™ 137204
Gc America Inc.
137204 / 13720410386040005364
Single use: no
On the market
EXAlence™ 137204
Gc America Inc.
137204 / 137204D6581372041
Single use: no
On the market
EXAlence™ 137224
Gc America Inc.
137224 / 13722410386040013352
Single use: no
On the market
EXAlence™ 137270
Gc America Inc.
137270 / 137270D6581372701
Single use: no
On the market
EXAlence™ 137270
Gc America Inc.
137270 / 13727010386040001458
Single use: no
On the market
EXAlence™ 137334
Gc America Inc.
137334 / 13733410386040013369
Single use: no
On the market
EXAlence™ 137334
Gc America Inc.
137334 / 137334D6581373341
Single use: no
On the market
EXAlence™ 137370
Gc America Inc.
137370 / 137370D6581373701
Total Volume 370 mL
Single use: no
On the market
EXAlence™ 137404
Gc America Inc.
137404 / 13740410386040005562
Single use: no
On the market
EXAlence™ 137444
Gc America Inc.
137444 / 13744410386040005586
Single use: no
On the market
EXAlence™ 137470
Gc America Inc.
137470 / 137470D6581374701
Total Volume 370 mL
Single use: no
On the market
EXAlence™ 137519
Gc America Inc.
137519 / 137519D6581375191
Single use: no
No longer on the market
EXAlence™ 137570
Gc America Inc.
137570 / 137570D6581375701
Single use: no
No longer on the market
EXAlence™ 137669
Gc America Inc.
137669 / 137669D6581376691
Single use: no
No longer on the market
EXAlence™ 137700
Gc America Inc.
137700 / 13770010386040005692
Total Volume 48 mL
Single use: no
On the market
EXAlence™ 137701
Gc America Inc.
137701 / 13770110386040005708
Single use: no
On the market
EXAlence™ 137701
Gc America Inc.
137701 / 137701D6581377011
Single use: no
On the market
EXAlence™ 137702
Gc America Inc.
137702 / 137702D6581377021
Single use: no
On the market
EXAlence™ 137702
Gc America Inc.
137702 / 13770210386040005715
Single use: no
On the market
EXAlence™ 137703
Gc America Inc.
137703 / 13770310386040005722
Single use: no
On the market
EXAlence™ 137705
Gc America Inc.
137705 / 137705D6581377051
Total Volume 48 mL
Single use: no
On the market
EXAlence™ 137707
Gc America Inc.
137707 / 137707D6581377071
Single use: no
On the market
EXAlence™ 137707
Gc America Inc.
137707 / 13770710386040013376
Single use: no
On the market
EXAlence™ 137708
Gc America Inc.
137708 / 137708D6581377081
Single use: no
On the market
EXAlence™ 137709
Gc America Inc.
137709 / 13770910386040005753
Single use: no
On the market
EXAlence™ 137710
Gc America Inc.
137710 / 13771010386040005760
Total Volume 48 mL
Single use: no
On the market
EXAlence™ 137712
Gc America Inc.
137712 / 13771210386040005777
Single use: no
On the market
EXAlence™ 137713
Gc America Inc.
137713 / 137713D6581377131
Single use: no
On the market
EXAlence™ 137713
Gc America Inc.
137713 / 13771310386040005784
Single use: no
On the market
EXAlence™ 137714
Gc America Inc.
137714 / 137714D6581377141
Single use: no
On the market
EXAlence™ 137714
Gc America Inc.
137714 / 13771410386040005791
Single use: no
On the market
EXAlence™ 137715
Gc America Inc.
137715 / 137715D6581377151
Total Volume 48 mL
Single use: no
On the market
EXAlence™ 137717
Gc America Inc.
137717 / 13771710386040013390
Single use: no
On the market
EXAlence™ 137718
Gc America Inc.
137718 / 13771810386040013406
Single use: no
On the market
EXAlence™ 137718
Gc America Inc.
137718 / 137718D6581377181
Single use: no
On the market
EXAlence™ 137719
Gc America Inc.
137719 / 137719D6581377191
Single use: no
On the market
EXAlence™ 137862
Gc America Inc.
137862 / 13786210386040001571
Total Volume 370 mL
Single use: no
On the market
EXAlence™ 137863
Gc America Inc.
137863 / 13786310386040001588
Single use: no
On the market
EXAlence™ 137864
Gc America Inc.
137864 / 13786410386040001595
Total Volume 370 mL
Single use: no
On the market
EXAlence™ 137870
Gc America Inc.
137870 / 137870D6581378701
Total Volume 370 mL
Single use: no
On the market
EXAlence™ 137870
Gc America Inc.
137870 / 13787010386040001649
Single use: no
On the market
EXAlence™ 137902
Gc America Inc.
137902 / 137902D6581379021
Single use: no
On the market
EXAlence™ 137902
Gc America Inc.
137902 / 13790210386040005838
Total Volume 370 mL
Single use: no
On the market
EXAlence™ 137970
Gc America Inc.
137970 / 13797010386040001762
Single use: no
On the market
EXAlence™ 150005
Gc America Inc.
150005 / 15000510386040006095
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code ELW (Material, Impression).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →