The following data is part of a premarket notification filed by Dentalez, Inc. with the FDA for Starcare Handpiece Maintenance Unit.
| Device ID | K093072 |
| 510k Number | K093072 |
| Device Name: | STARCARE HANDPIECE MAINTENANCE UNIT |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTALEZ, INC. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Kay Engle |
| Correspondent | Kay Engle 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 | 2009-09-30 |
| Decision Date | 2009-12-28 |
| Summary: | summary |