The following data is part of a premarket notification filed by Dentalez Group with the FDA for Star Titan Series Motors & Attachments.
Device ID | K960260 |
510k Number | K960260 |
Device Name: | STAR TITAN SERIES MOTORS & ATTACHMENTS |
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 | 1996-01-18 |
Decision Date | 1996-03-28 |
Summary: | summary |