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Mfp-051

by Gc America Inc.

510(k) K123631

Mfp-051 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K123631 on 23 Jul 2013, 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 NumberK123631 Date23 Jul 2013ClearedStatusActive

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  • Withdrawn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 K123631

106 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 K123631
UDI-DISize and differences
G-aenial™ 009152
Gc America Inc.
009152 / 00915214548161327237
Single use: no
On the market
G-aenial™ 009152
Gc America Inc.
009152 / 009152D0470091521
Single use: no
On the market
G-aenial™ 009154
Gc America Inc.
009154 / 00915414548161327251
Single use: no
On the market
G-aenial™ 009155
Gc America Inc.
009155 / 00915514548161327268
Single use: no
On the market
G-aenial™ 009157
Gc America Inc.
009157 / 00915714548161327282
Single use: no
On the market
G-aenial™ 009159
Gc America Inc.
009159 / 00915914548161327305
Single use: no
On the market
G-aenial™ 009160
Gc America Inc.
009160 / 00916014548161327312
Single use: no
On the market
G-aenial™ 009162
Gc America Inc.
009162 / 009162D0470091621
Single use: no
On the market
G-aenial™ 009163
Gc America Inc.
009163 / 009163D0470091631
Single use: no
On the market
G-aenial™ 009163
Gc America Inc.
009163 / 00916314548161327343
Single use: no
On the market
G-aenial™ 009165
Gc America Inc.
009165 / 00916514548161327367
Single use: no
On the market
G-aenial™ 009165
Gc America Inc.
009165 / 009165D0470091651
Single use: no
On the market
G-aenial™ 009167
Gc America Inc.
009167 / 00916714548161327381
Single use: no
On the market
G-aenial™ 009167
Gc America Inc.
009167 / 009167D0470091671
Single use: no
On the market
G-aenial™ 009169
Gc America Inc.
009169 / 00916914548161327404
Single use: yes
On the market
G-aenial™ 009170
Gc America Inc.
009170 / 009170D0470091701
Single use: yes
On the market
G-aenial™ 009171
Gc America Inc.
009171 / 009171D0470091711
Single use: yes
On the market
G-aenial™ 009173
Gc America Inc.
009173 / 009173D0470091731
Single use: yes
On the market
G-aenial™ 009176
Gc America Inc.
009176 / 009176D0470091761
Single use: yes
On the market
G-aenial™ 009176
Gc America Inc.
009176 / 00917614548161327473
Single use: yes
On the market
G-aenial™ 009177
Gc America Inc.
009177 / 00917714548161327480
Single use: yes
On the market
G-aenial™ 009178
Gc America Inc.
009178 / 009178D0470091781
Single use: yes
On the market
G-aenial™ 009178
Gc America Inc.
009178 / 00917814548161327497
Single use: yes
On the market
G-aenial™ 009179
Gc America Inc.
009179 / 00917914548161327503
Single use: yes
On the market
G-aenial™ 009181
Gc America Inc.
009181 / 009181D0470091811
Single use: yes
On the market
G-aenial™ 009181
Gc America Inc.
009181 / 00918114548161327527
Single use: yes
On the market
G-aenial™ 009183
Gc America Inc.
009183 / 00918314548161327541
Single use: yes
On the market
G-aenial™ 009184
Gc America Inc.
009184 / 009184D0470091841
Single use: yes
On the market
G-aenial™ 009184
Gc America Inc.
009184 / 00918414548161327558
Single use: yes
On the market
G-aenial™ 009185
Gc America Inc.
009185 / 009185D0470091851
Single use: yes
On the market
G-aenial™ 401000
Gc America Inc.
401000 / 401000D6584010001
Single use: no
On the market
G-aenial™ 952230
Gc America Inc.
952230 / 95223015400556015060
Single use: no
On the market
G-aenial™ 952233
Gc America Inc.
952233 / 95223315400556015091
Single use: no
On the market
G-aenial™ 952238
Gc America Inc.
952238 / 95223815400556015145
Single use: no
On the market
G-aenial™ 952240
Gc America Inc.
952240 / 95224015400556015169
Single use: no
On the market
G-aenial™ 952241
Gc America Inc.
952241 / 95224115400556015176
Single use: no
On the market
G-aenial™ 952242
Gc America Inc.
952242 / 95224215400556015183
Single use: no
On the market
G-aenial™ 952243
Gc America Inc.
952243 / 95224315400556015190
Single use: no
On the market
G-aenial™ 952244
Gc America Inc.
952244 / 95224415400556015206
Single use: yes
On the market
G-aenial™ 952246
Gc America Inc.
952246 / 95224615400556015220
Single use: yes
On the market
G-aenial™ 952247
Gc America Inc.
952247 / 95224715400556015237
Single use: yes
On the market
G-aenial™ 952248
Gc America Inc.
952248 / 95224815400556015244
Single use: yes
On the market
G-aenial™ 952249
Gc America Inc.
952249 / 95224915400556015251
Single use: yes
On the market
G-aenial™ 952252
Gc America Inc.
952252 / 95225215400556015282
Single use: yes
On the market
G-aenial™ 952253
Gc America Inc.
952253 / 95225315400556015299
Single use: yes
On the market
G-aenial™ 952254
Gc America Inc.
952254 / 95225415400556015305
Single use: yes
On the market
G-aenial™ 952255
Gc America Inc.
952255 / 95225515400556015312
Single use: yes
On the market
G-aenial™ 952257
Gc America Inc.
952257 / 95225715400556015336
Single use: yes
On the market
G-aenial™ 952260
Gc America Inc.
952260 / 95226015400556015367
Single use: yes
On the market
G-aenial™ 952263
Gc America Inc.
952263 / 95226315400556015398
Single use: yes
On the market

Similar devices

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