Cerasmart
510(k) K133824
Cerasmart is a Class II device made by Gc America Inc., cleared under FDA 510(k) K133824 on 14 Mar 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133824 | Date14 Mar 2014 | StatusActive |
Official records
- FDA 510(k) database K133824
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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 K133824
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.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CERASMART® 008343 | 008343 / 008343 | D0470083431 | — | On the market |
| CERASMART® 008346 | 008346 / 008346 | D0470083461 | — | On the market |
| CERASMART® 008347 | 008347 / 008347 | D0470083471 | — | On the market |
| CERASMART® 008348 | 008348 / 008348 | D0470083481 | — | On the market |
| CERASMART® 008349 | 008349 / 008349 | D0470083491 | — | On the market |
| CERASMART® 008356 | 008356 / 008356 | D0470083561 | — | On the market |
| CERASMART® 008369 | 008369 / 008369 | D0470083691 | — | On the market |
| CERASMART® 008373 | 008373 / 008373 | D0470083731 | — | On the market |
| CERASMART® 008374 | 008374 / 008374 | D0470083741 | — | On the market |
| CERASMART® 008379 | 008379 / 008379 | D0470083791 | — | On the market |
| CERASMART® 008384 | 008384 / 008384 | D0470083841 | — | On the market |
| CERASMART® 008388 | 008388 / 008388 | D0470083881 | — | On the market |
| CERASMART® 008390 | 008390 / 008390 | D0470083901 | — | On the market |
| CERASMART® 008392 | 008392 / 008392 | D0470083921 | — | On the market |
| CERASMART® 008393 | 008393 / 008393 | D0470083931 | — | On the market |
| CERASMART® 008396 | 008396 / 008396 | D0470083961 | — | On the market |
| CERASMART® 008402 | 008402 / 008402 | D0470084021 | — | On the market |
| CERASMART® 008405 | 008405 / 008405 | D0470084051 | — | On the market |
| CERASMART® 008653 | 008653 / 008653 | D0470086531 | — | On the market |
| CERASMART® 008656 | 008656 / 008656 | D0470086561 | — | On the market |
| CERASMART® 008659 | 008659 / 008659 | D0470086591 | — | On the market |
| CERASMART® 008671 | 008671 / 008671 | D0470086711 | — | On the market |
| CERASMART® 008676 | 008676 / 008676 | D0470086761 | — | On the market |
| CERASMART® 011960 | 011960 / 011960 | D0470119601 | — | No longer on the market |
| CERASMART® 012397 | 012397 / 012397 | D0470123971 | — | On the market |
| CERASMART® 012401 | 012401 / 012401 | D0470124011 | — | On the market |
| CERASMART® 012401 | 012401 / 012401 | 14548161320092 | — | On the market |
| CERASMART® 012402 | 012402 / 012402 | 14548161320108 | — | On the market |
| CERASMART® 012403 | 012403 / 012403 | D0470124031 | — | On the market |
| CERASMART® 012404 | 012404 / 012404 | D0470124041 | — | On the market |
| CERASMART® 012408 | 012408 / 012408 | D0470124081 | — | On the market |
| CERASMART® 012410 | 012410 / 012410 | D0470124101 | — | On the market |
| CERASMART® 012444 | 012444 / 012444 | D0470124441 | — | On the market |
| CERASMART® 012445 | 012445 / 012445 | D0470124451 | — | On the market |
| CERASMART® 012459 | 012459 / 012459 | D0470124591 | — | On the market |
| CERASMART® 012460 | 012460 / 012460 | D0470124601 | — | On the market |
| CERASMART® 012461 | 012461 / 012461 | D0470124611 | — | On the market |
| CERASMART® 012462 | 012462 / 012462 | D0470124621 | — | On the market |
| CERASMART® 012496 | 012496 / 012496 | D0470124961 | — | On the market |
| CERASMART® 012500 | 012500 / 012500 | D0470125001 | — | On the market |
| CERASMART® 012503 | 012503 / 012503 | D0470125031 | — | On the market |
| CERASMART® 012506 | 012506 / 012506 | D0470125061 | — | On the market |
| CERASMART® 012514 | 012514 / 012514 | D0470125141 | — | On the market |
| CERASMART™ 012415 | 012415 / 012415 | 14548161320238 | — | On the market |
| CERASMART™ 012445 | 012445 / 012445 | 14548161320283 | — | On the market |
| CERASMART™ 012450 | 012450 / 012450 | 14548161320344 | — | On the market |
| CERASMART™ 012494 | 012494 / 012494 | 14548161320542 | — | On the market |
| CERASMART™ 012502 | 012502 / 012502 | 14548161320610 | — | On the market |
| CERASMART™ 012507 | 012507 / 012507 | 14548161320917 | — | On the market |
| CERASMART™ 012512 | 012512 / 012512 | 14548161320962 | — | On the market |
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