The following data is part of a premarket notification filed by Star Dental Mfg. Co. with the FDA for High Speed Cereamic Bearing Turbine Handpieces.
| Device ID | K905155 |
| 510k Number | K905155 |
| Device Name: | HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | STAR DENTAL MFG. CO. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Gary Foss |
| Correspondent | Gary Foss STAR DENTAL MFG. CO. 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 | 1990-11-15 |
| Decision Date | 1991-02-13 |