The following data is part of a premarket notification filed by Sable Industries, Inc. with the FDA for Access And Rotamax Fiber Optic High Speed Dental Handpieces.
| Device ID | K072554 |
| 510k Number | K072554 |
| Device Name: | ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SABLE INDUSTRIES, INC. 581 WHILES COURT Erie, CO 80516 |
| Contact | Kevin Randall |
| Correspondent | Kevin Randall SABLE INDUSTRIES, INC. 581 WHILES COURT Erie, CO 80516 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-10 |
| Decision Date | 2007-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841359010049 | K072554 | 000 |
| 00841359050021 | K072554 | 000 |
| 00841359050038 | K072554 | 000 |
| 00841359050045 | K072554 | 000 |
| 00841359050052 | K072554 | 000 |
| 00841359050069 | K072554 | 000 |
| 00841359050076 | K072554 | 000 |
| 00841359010056 | K072554 | 000 |
| 00841359010063 | K072554 | 000 |
| 00841359010018 | K072554 | 000 |
| 00841359010025 | K072554 | 000 |
| 00841359010032 | K072554 | 000 |
| 00841359050014 | K072554 | 000 |