Miniblaster
by Deldent Ltd.
510(k) K013969
Miniblaster is a medical device (FDA Class II; FDA product code KOJ, Airbrush) made by Deldent Ltd., cleared under FDA 510(k) K013969 on 10 Jan 2002, 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 | NumberK013969 | Date10 Jan 2002 | StatusActive |
Official records
- FDA 510(k) database K013969
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KOJ
- FDA applicant
- Deldent , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6080
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K013969
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 | |||
|---|---|---|---|---|
| Henry Schein 1015623 | 1015623 / 1015623 | 00304040007440 | Weight 21 g | On the market |
| Henry Schein 1015624 | 1015624 / 1015624 | 00304040007457 | Weight 23 g | On the market |
| Henry Schein 1017004 | 1017004 / 1017004 | 00304040007426 | Weight 215 g | On the market |
| Johnson-Promident 505000 | 505000 / 505000 | 00816577020347 | On the market | |
| Johnson-Promident 505105 | 505105 / 505105 | 00816577020361 | On the market | |
| Johnson-Promident 505108 | 505108 / 505108 | 00816577020378 | On the market | |
| Johnson-Promident 505110 | 505110 / 505110 | 00816577020385 | On the market | |
| Johnson-Promident 505113 | 505113 / 505113 | 00840326403518 | On the market | |
| Johnson-Promident 505116 | 505116 / 505116 | 00840326418451 | On the market | |
| Johnson-Promident 505119 | 505119 / 505119 | 00840326418468 | On the market | |
| Johnson-Promident 505121 | 505121 / 505121 | 00840326418475 | On the market | |
| Johnson-Promident 505126 | 505126 / 505126 | 00840326418482 | On the market | |
| Johnson-Promident 505128 | 505128 / 505128 | 00840326418499 | On the market | |
| Johnson-Promident 505129 | 505129 / 505129 | 00840326418505 | On the market | |
| MB coupling Borden 505112 | 505112 / 505112 | 07290016281033 | On the market | |
| MB coupling Midwest 505111 | 505111 / 505111 | 07290016281026 | On the market | |
| MB Quick coupling Kavo 505113 | 505113 / 505113 | 07290016281040 | On the market | |
| MB Quick coupling Sirona 505114 | 505114 / 505114 | 07290016281057 | On the market | |
| MB Quick coupling W&H 505117 | 505117 / 505117 | 07290016281064 | On the market | |
| Miniblaster Nozzle Extension 505130 | 505130 | 07290016281019 | On the market | |
| Miniblaster Unit 505000 | 505000 | 07290016281002 | On the market |
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Other devices filed under FDA product code KOJ (Airbrush).
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