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Initial LiSi Press

by Gc America Inc.

510(k) K153136

Initial LiSi Press is a Class II device made by Gc America Inc., cleared under FDA 510(k) K153136 on 30 Jun 2016, 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 NumberK153136 Date30 Jun 2016ClearedStatusActive

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  • Withdrawn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
EIH
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.6660
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

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

Devices cleared under K153136

90 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 K153136
UDI-DISize and differences
GC Initial™ 010320
Gc America Inc.
010320 / 010320D0470103201 —On the market
GC Initial™ 010321
Gc America Inc.
010321 / 010321D0470103211 —On the market
GC Initial™ 010322
Gc America Inc.
010322 / 01032214548161315203 —On the market
GC Initial™ 010322
Gc America Inc.
010322 / 010322D0470103221 —On the market
GC Initial™ 010323
Gc America Inc.
010323 / 010323D0470103231 —On the market
GC Initial™ 010324
Gc America Inc.
010324 / 01032414548161315425 —On the market
GC Initial™ 010325
Gc America Inc.
010325 / 01032514548161315531 —On the market
GC Initial™ 010326
Gc America Inc.
010326 / 010326D0470103261 —On the market
GC Initial™ 010328
Gc America Inc.
010328 / 010328D0470103281 —On the market
GC Initial™ 010332
Gc America Inc.
010332 / 010332D0470103321 —On the market
GC Initial™ 010333
Gc America Inc.
010333 / 010333D0470103331 —On the market
GC Initial™ 010334
Gc America Inc.
010334 / 01033414548161315043 —On the market
GC Initial™ 010335
Gc America Inc.
010335 / 010335D0470103351 —On the market
GC Initial™ 010336
Gc America Inc.
010336 / 01033614548161315067 —On the market
GC Initial™ 010337
Gc America Inc.
010337 / 01033714548161315074 —On the market
GC Initial™ 010338
Gc America Inc.
010338 / 01033814548161315081 —On the market
GC Initial™ 010339
Gc America Inc.
010339 / 010339D0470103391 —On the market
GC Initial™ 010340
Gc America Inc.
010340 / 01034014548161315111 —On the market
GC Initial™ 010341
Gc America Inc.
010341 / 01034114548161315128 —On the market
GC Initial™ 010341
Gc America Inc.
010341 / 010341D0470103411 —On the market
GC Initial™ 010342
Gc America Inc.
010342 / 010342D0470103421 —On the market
GC Initial™ 012825
Gc America Inc.
012825 / 012825D0470128251 —On the market
GC Initial™ 012828
Gc America Inc.
012828 / 012828D0470128281 —On the market
GC Initial™ 012830
Gc America Inc.
012830 / 012830D0470128301 —On the market
GC Initial™ 012831
Gc America Inc.
012831 / 012831D0470128311 —On the market
GC Initial™ 012834
Gc America Inc.
012834 / 012834D0470128341 —On the market
GC Initial™ 012837
Gc America Inc.
012837 / 01283714548161315562 —On the market
GC Initial™ 012838
Gc America Inc.
012838 / 01283814548161315579 —On the market
GC Initial™ 012840
Gc America Inc.
012840 / 012840D0470128401 —On the market
GC Initial™ 012840
Gc America Inc.
012840 / 01284014548161315593 —On the market
GC Initial™ 012841
Gc America Inc.
012841 / 01284114548161315609 —On the market
GC Initial™ 012842
Gc America Inc.
012842 / 01284214548161315616 —On the market
GC Initial™ 012842
Gc America Inc.
012842 / 012842D0470128421 —On the market
GC Initial™ 012843
Gc America Inc.
012843 / 01284314548161315623 —On the market
GC Initial™ 012845
Gc America Inc.
012845 / 01284514548161315654 —On the market
GC Initial™ 012846
Gc America Inc.
012846 / 012846D0470128461 —On the market
GC Initial™ 012848
Gc America Inc.
012848 / 01284814548161315685 —On the market
GC Initial™ 012850
Gc America Inc.
012850 / 012850D0470128501 —On the market
GC Initial™ 012851
Gc America Inc.
012851 / 01285114548161315715 —On the market
GC Initial™ 012853
Gc America Inc.
012853 / 012853D0470128531 —On the market

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