The following data is part of a premarket notification filed by Dentalez Group with the FDA for Star Dental 430 Series High Speed Handpiece.
| Device ID | K960719 |
| 510k Number | K960719 |
| Device Name: | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Jeff Peinhardt |
| Correspondent | Jeff Peinhardt DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-21 |
| Decision Date | 1996-03-28 |
| Summary: | summary |