DentalJect
510(k) K243654
DentalJect is a medical device (FDA unclassified; FDA product code MLY, Vapocoolant Device) made by Vapocoolshot, Inc, cleared under FDA 510(k) K243654 on 30 May 2025, active as of 10 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 | NumberK243654 | Date30 May 2025 | StatusActive |
Official records
- FDA 510(k) database K243654
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MLY
- FDA applicant
- Vapocoolshot, Inc.
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K243654
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 | |||
|---|---|---|---|---|
| DentalJect Applicator DJ01000-00 | DJ01000-00 / DJ01000-00 | 00860010587355 | — | On the market |
| DentalJect Applicator Set DJ04000-00 | DJ04000-00 | 00860010587379 | — | On the market |
| DentalJect Canister DJ03000-01 | DJ03000-01 | 00860010587348 | — | On the market |
| DentalJect Intro Bundle DJ07000-00 | DJ07000-00 | 00860016151314 | — | On the market |
| DentalJect Single Kit DJ01300-00 | DJ01300-00 | 00860016151307 | — | On the market |
| DentalJect Starter Kit - No Syringe Connector DJ06000-00 | DJ06000-00 / DJ06000-00 | 00860010587393 | — | On the market |
| DentalJect Starter Kit DJ05000-00 | DJ05000-00 | 00860010587386 | — | On the market |
| DentalJect Syringe Connector DJ02000-00 | DJ02000-00 / DJ02000-00 | 00860010587362 | — | On the market |
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