510(k) K984380
- Device
- DISPO ETCH
- Applicant
- KIS PRODUCTS
- 510(k) number
- K984380
- Product code
- KOJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-06
- Date received
- 1998-12-08
- Regulation
- 872.6080
- Classification name
- Airbrush
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- REUBEN HERTZ
- Address
- 2318 Sea Island Dr. Fort Lauderdale FL US 33301 33301
FDA Registration Numbers#
- 2029314
- 3038718579
- 2024980
- 1416605
- 3009968482
- 1420089
- 2023950
- 3002807310
- 8030987
- 9616762
- 3003637274
- 9611253
- 3004096429
- 1413475
- 3005581016
- 2411797
- 9613230
- 3012421607
- 3003933619
- 2424472
- 3010664129
- 1422375
- 3004361444
- 3003982003
- 3005972890
Source Documents#
Other 510(k) Records For Product Code KOJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251425 | turbodent touch | Mectron S.P.A. | 2025-05-09 |
| K063236 | BETA-POWDER | Brainbase Corporation | 2007-02-16 |
| K042872 | RONDOFLEX PLUS 360 | Kavo America Corporation | 2004-11-23 |
| K033675 | PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER | Sirona Dental Systems GmbH | 2004-01-15 |
| K033215 | PREPAIR | Danville Materials, Inc. | 2004-01-09 |
| K024105 | VELOPEX AQUACUT FLUID ABRASION UNIT | Velopex International, Inc. | 2003-10-09 |
| K030292 | GROMAN PREPMASTER | Groman, Inc. | 2003-04-15 |
| K021450 | CLINPRO PROPHY POWDER | 3M Espe AG Dental Products | 2002-08-01 |
| K014188 | NEW PROPHY POWDER | Dentsply Intl. | 2002-03-15 |
| K014249 | JETPOLISHER | Deldent , Ltd. | 2002-02-19 |
| K014252 | JETSTREAM | Deldent , Ltd. | 2002-02-19 |
| K014245 | JETSONIC 2000 | Deldent , Ltd. | 2002-01-29 |
| K013969 | MINIBLASTER | Deldent , Ltd. | 2002-01-10 |
| K993124 | DISPODRILL | Kis Products | 2001-08-06 |
| K993182 | DISPOPROPHY | Kis Products | 2001-08-06 |
Legacy Summary#
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FDA Review#
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