Submission Details
| 510(k) Number | K070327 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 2007 |
| Decision Date | May 25, 2007 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K070327 is an FDA 510(k) clearance for the REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on May 25, 2007, 109 days after receiving the submission on February 5, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K070327 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 2007 |
| Decision Date | May 25, 2007 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK — Device, Anti-snoring |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.5570 |