The following data is part of a premarket notification filed by Orthosource, Inc. with the FDA for Excel High Speed Dental Handpiece.
| Device ID | K061581 |
| 510k Number | K061581 |
| Device Name: | EXCEL HIGH SPEED DENTAL HANDPIECE |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | ORTHOSOURCE, INC. 13343 SHERMAN WAY North Hollywood, CA 91605 |
| Contact | Lloyd Taylor |
| Correspondent | Lloyd Taylor ORTHOSOURCE, INC. 13343 SHERMAN WAY North Hollywood, CA 91605 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-07 |
| Decision Date | 2006-08-16 |