FDA Product Code
FDA Product Code ORY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5570
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213159 | Encore System | Siesta Medical, Inc. | 2021-12-22 | Traditional | PDF ↗ |
| K201238 | Encore System | Siesta Medical, Inc. | 2020-10-02 | Special | PDF ↗ |
| K183310 | Encore System | Siesta Medical, Inc. | 2019-05-09 | Traditional | PDF ↗ |
| K133680 | ENCORE SYSTEM | Siesta Medical, Inc. | 2014-03-26 | Traditional | PDF ↗ |
| K121440 | ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT | Siesta Medical, Inc. | 2012-12-06 | Traditional | PDF ↗ |
| K121814 | ENCORE TONGUE SUSPENSION SYSTEM | Siesta Medical, Inc. | 2012-11-07 | Traditional | PDF ↗ |
| K111179 | ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN | Siesta Medical, Inc. | 2011-07-01 | Special | PDF ↗ |
| K110127 | PRELUDE III TONGUE SUSPENSION SYSTEM | Siesta Medical, Inc. | 2011-04-08 | Special | PDF ↗ |
| K103179 | PRELUDE II TOUNGE SUSPENSION SYSTEM | Siesta Medical, Inc. | 2010-12-20 | Special | PDF ↗ |
| K101060 | SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM | Siesta Medical, Inc. | 2010-07-08 | Traditional | PDF ↗ |
Product code ORY · Class II · Dental. Data: openFDA.