The following data is part of a premarket notification filed by Sable Industries, Inc. with the FDA for Premium Slow Speed; 20k Air Motor, Heads, Contra-angles, Straight Nosecones.
| Device ID | K083101 |
| 510k Number | K083101 |
| Device Name: | PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SABLE INDUSTRIES, INC. 16576 W. 53rd Way Golden, CO 80403 |
| Contact | Kevin Randall |
| Correspondent | Kevin Randall SABLE INDUSTRIES, INC. 16576 W. 53rd Way Golden, CO 80403 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-20 |
| Decision Date | 2009-02-23 |
| Summary: | summary |