The following data is part of a premarket notification filed by Shanghai Dental Instrument Factory with the FDA for Cst61 High Speed Turbine Handpiece.
| Device ID | K063110 |
| 510k Number | K063110 |
| Device Name: | CST61 HIGH SPEED TURBINE HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SHANGHAI DENTAL INSTRUMENT FACTORY 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-10-11 |
| Decision Date | 2006-10-26 |
| Summary: | summary |