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Mi Flow (Gcuc-450)

by Gc America Inc.

510(k) K090747

Mi Flow (Gcuc-450) is a Class II device made by Gc America Inc., cleared under FDA 510(k) K090747 on 10 Jun 2009, 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 NumberK090747 Date10 Jun 2009ClearedStatusActive

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  • Withdrawn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

Devices cleared under K090747

20 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 K090747
UDI-DISize and differences
G-aenial™ 004194
Gc America Inc.
004194 / 004194D0470041941
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004194
Gc America Inc.
004194 / 00419414548161323116
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004195
Gc America Inc.
004195 / 004195D0470041951
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004195
Gc America Inc.
004195 / 00419514548161323123
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004196
Gc America Inc.
004196 / 00419614548161323130
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004196
Gc America Inc.
004196 / 004196D0470041961
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004197
Gc America Inc.
004197 / 004197D0470041971
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004197
Gc America Inc.
004197 / 00419714548161323147
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004198
Gc America Inc.
004198 / 00419814548161323154
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004198
Gc America Inc.
004198 / 004198D0470041981
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004199
Gc America Inc.
004199 / 00419914548161323161
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004199
Gc America Inc.
004199 / 004199D0470041991
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004200
Gc America Inc.
004200 / 004200D0470042001
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004200
Gc America Inc.
004200 / 00420014548161323178
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004201
Gc America Inc.
004201 / 00420114548161323185
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004201
Gc America Inc.
004201 / 004201D0470042011
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004634
Gc America Inc.
004634 / 00463414548161283373
Single use: yes
On the market
G-aenial™ 004634
Gc America Inc.
004634 / 004634D0470046341
Single use: yes
On the market
G-aenial™ 004635
Gc America Inc.
004635 / 004635D0470046351
Single use: yes
On the market
G-aenial™ 004635
Gc America Inc.
004635 / 00463514548161283007
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code EBF (Material, Tooth Shade, Resin).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →