The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for New Prophy Powder.
| Device ID | K014188 |
| 510k Number | K014188 |
| Device Name: | NEW PROPHY POWDER |
| Classification | Airbrush |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-03-15 |
| Summary: | summary |