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Gcuc-505

by Gc America Inc.

510(k) K091388

Gcuc-505 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K091388 on 22 Jul 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 NumberK091388 Date22 Jul 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  • Withdrawn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

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 K091388

36 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 K091388
UDI-DISize and differences
G-aenial™ 004202
Gc America Inc.
004202 / 004202D0470042021
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004202
Gc America Inc.
004202 / 00420214548161323192
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004203
Gc America Inc.
004203 / 00420314548161323208
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004203
Gc America Inc.
004203 / 004203D0470042031
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004204
Gc America Inc.
004204 / 004204D0470042041
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004204
Gc America Inc.
004204 / 00420414548161323215
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004205
Gc America Inc.
004205 / 00420514548161323222
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004205
Gc America Inc.
004205 / 004205D0470042051
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004206
Gc America Inc.
004206 / 004206D0470042061
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004206
Gc America Inc.
004206 / 00420614548161323239
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004207
Gc America Inc.
004207 / 00420714548161323246
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004207
Gc America Inc.
004207 / 004207D0470042071
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004208
Gc America Inc.
004208 / 004208D0470042081
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004208
Gc America Inc.
004208 / 00420814548161323253
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004209
Gc America Inc.
004209 / 00420914548161323260
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004209
Gc America Inc.
004209 / 004209D0470042091
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004210
Gc America Inc.
004210 / 00421014548161323277
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004210
Gc America Inc.
004210 / 004210D0470042101
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004211
Gc America Inc.
004211 / 004211D0470042111
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004211
Gc America Inc.
004211 / 00421114548161323284
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004212
Gc America Inc.
004212 / 004212D0470042121
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004212
Gc America Inc.
004212 / 00421214548161323291
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004213
Gc America Inc.
004213 / 00421314548161323307
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004213
Gc America Inc.
004213 / 004213D0470042131
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004214
Gc America Inc.
004214 / 004214D0470042141
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004214
Gc America Inc.
004214 / 00421414548161323314
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004215
Gc America Inc.
004215 / 004215D0470042151
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004215
Gc America Inc.
004215 / 00421514548161323321
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004216
Gc America Inc.
004216 / 00421614548161323338
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 004216
Gc America Inc.
004216 / 004216D0470042161
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
G-aenial™ 008468
Gc America Inc.
008468 / 00846814548161323345
Total Volume 2 mL
Single use: no
On the market
G-aenial™ 008468
Gc America Inc.
008468 / 008468D0470084681
Total Volume 2 mL
Single use: no
On the market

Similar devices

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

Other devices from Gc America Inc.

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