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 |