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NMF004A

by Gc America Inc.

510(k) K173500

NMF004A is a Class II device made by Gc America Inc., cleared under FDA 510(k) K173500 on 8 Mar 2018, 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 NumberK173500 Date8 Mar 2018ClearedStatusActive

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  • Withdrawn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
EBF
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3690
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

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

Cites

Cited by

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

Devices cleared under K173500

51 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 K173500
UDI-DISize and differences
G-aenial™ 012281
Gc America Inc.
012281 / 012281D0470122811
Single use: yes
On the market
G-aenial™ 012281
Gc America Inc.
012281 / 01228114548161337656
Single use: yes
On the market
G-aenial™ 012348
Gc America Inc.
012348 / 012348D0470123481
Single use: no
On the market
G-aenial™ 012349
Gc America Inc.
012349 / 012349D0470123491
Single use: no
On the market
G-aenial™ 012350
Gc America Inc.
012350 / 012350D0470123501
Single use: no
On the market
G-aenial™ 012351
Gc America Inc.
012351 / 012351D0470123511
Single use: no
On the market
G-aenial™ 012352
Gc America Inc.
012352 / 012352D0470123521
Single use: no
On the market
G-aenial™ 012353
Gc America Inc.
012353 / 012353D0470123531
Single use: no
On the market
G-aenial™ 012354
Gc America Inc.
012354 / 012354D0470123541
Single use: no
On the market
G-aenial™ 012355
Gc America Inc.
012355 / 012355D0470123551
Single use: no
On the market
G-aenial™ 012356
Gc America Inc.
012356 / 012356D0470123561
Single use: no
On the market
G-aenial™ 012357
Gc America Inc.
012357 / 012357D0470123571
Single use: no
On the market
G-aenial™ 012358
Gc America Inc.
012358 / 012358D0470123581
Single use: no
On the market
G-aenial™ 012359
Gc America Inc.
012359 / 012359D0470123591
Single use: no
On the market
G-aenial™ 012360
Gc America Inc.
012360 / 012360D0470123601
Single use: no
On the market
G-aenial™ 012361
Gc America Inc.
012361 / 012361D0470123611
Single use: no
On the market
G-aenial™ 012362
Gc America Inc.
012362 / 012362D0470123621
Single use: no
On the market
G-aenial™ 012363
Gc America Inc.
012363 / 012363D0470123631
Single use: no
On the market
G-aenial™ 012364
Gc America Inc.
012364 / 012364D0170123641
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012364
Gc America Inc.
012364 / 01236414548161328562
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012365
Gc America Inc.
012365 / 012365D0470123651
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012366
Gc America Inc.
012366 / 012366D0470123661
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012367
Gc America Inc.
012367 / 012367D0470123671
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012368
Gc America Inc.
012368 / 012368D0470123681
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012368
Gc America Inc.
012368 / 01236814548161328609
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012369
Gc America Inc.
012369 / 012369D0470123691
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012369
Gc America Inc.
012369 / 01236914548161328616
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012370
Gc America Inc.
012370 / 01237014548161328623
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012371
Gc America Inc.
012371 / 012371D0470123711
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012371
Gc America Inc.
012371 / 01237114548161328630
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012372
Gc America Inc.
012372 / 01237214548161328647
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012372
Gc America Inc.
012372 / 012372D0470123721
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012373
Gc America Inc.
012373 / 01237314548161328654
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012373
Gc America Inc.
012373 / 012373D0470123731
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012374
Gc America Inc.
012374 / 01237414548161328661
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012374
Gc America Inc.
012374 / 012374D0470123741
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012375
Gc America Inc.
012375 / 01237514548161328678
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012375
Gc America Inc.
012375 / 012375D0470123751
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012376
Gc America Inc.
012376 / 012376D0470123761
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012376
Gc America Inc.
012376 / 01237614548161328685
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012377
Gc America Inc.
012377 / 01237714548161328692
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012377
Gc America Inc.
012377 / 012377D0470123771
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012378
Gc America Inc.
012378 / 01237814548161328708
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012378
Gc America Inc.
012378 / 012378D0470123781
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012379
Gc America Inc.
012379 / 01237914548161328715
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012379
Gc America Inc.
012379 / 012379D0470123791
Total Volume 1 mL
Single use: no
On the market
G-aenial™ 012394
Gc America Inc.
012394 / 01239414548161328722
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 012394
Gc America Inc.
012394 / 012394D0470123941
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 012395
Gc America Inc.
012395 / 01239514548161328739
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 012395
Gc America Inc.
012395 / 012395D0470123951
Total Volume 2 mL
Single use: no
On the market

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