The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Prosmile Air Polisher And Prophylaxis Powder.
| Device ID | K033675 |
| 510k Number | K033675 |
| Device Name: | PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER |
| Classification | Airbrush |
| Applicant | SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2004-01-15 |
| Summary: | summary |