Exajet
510(k) K023751
Exajet is a Class II device made by Gc America Inc., cleared under FDA 510(k) K023751 on 22 Jan 2003, 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 | NumberK023751 | Date22 Jan 2003 | StatusActive |
Official records
- FDA 510(k) database K023751
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELW
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K023751
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 | |||
|---|---|---|---|---|
| EXAJET™ 137611 | 137611 / 137611 | D6581376111 | — | On the market |
| EXAJET™ 137611 | 137611 / 137611 | 10386040005623 | — | On the market |
| EXAJET™ 137612 | 137612 / 137612 | D6581376121 | — | On the market |
| EXAJET™ 137612 | 137612 / 137612 | 10386040005630 | — | On the market |
| EXAJET™ 137613 | 137613 / 137613 | 10386040005647 | — | On the market |
| EXAJET™ 137613 | 137613 / 137613 | D6581376131 | — | On the market |
| EXAJET™ 137614 | 137614 / 137614 | 10386040005654 | — | On the market |
| EXAJET™ 137614 | 137614 / 137614 | D6581376141 | — | On the market |
| EXAJET™ 137615 | 137615 / 137615 | D6581376151 | — | On the market |
| EXAJET™ 137615 | 137615 / 137615 | 10386040005661 | — | On the market |
| EXAJET™ 137616 | 137616 / 137616 | D6581376161 | — | On the market |
| EXAJET™ 137616 | 137616 / 137616 | 10386040005678 | — | On the market |
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