The following data is part of a premarket notification filed by Dentalez, Inc. with the FDA for Prophy Star 3 Hygiene Handpiece, Model 264422.
| Device ID | K070869 |
| 510k Number | K070869 |
| Device Name: | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTALEZ, INC. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | William Guscott |
| Correspondent | William Guscott DENTALEZ, INC. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-29 |
| Decision Date | 2007-06-15 |
| Summary: | summary |