ELASTOMERIC SLEEP APPLIANCE
FDA 510(k) clearance K946112 · decided 1995-06-14
Clearance details
- K-number
- K946112
- Device name
- ELASTOMERIC SLEEP APPLIANCE
- Applicant
- Village Park Orthodontics
- Decision
- Substantially Equivalent
- Date received
- 1994-12-15
- Decision date
- 1995-06-14
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- LQZ
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Depew, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AIO Breathe (K233754) | Aiomega, LLC | 2024-02-23 |
| RADx Intraoral Appliance for Snoring and Sleep Apnea (K230532) | Achaemenid, LLC | 2023-07-12 |
| The Slide (K203712) | Biotex, Inc. | 2021-07-20 |
| Slow Wave DS8 (K191320) | Slow Wave, Inc. | 2020-10-02 |
| The NightBlocks Appliance (K192581) | Advanced Facialdontics, LLC | 2020-01-28 |
| SML-OSA2 Appliances (K162816) | Selane Products, Inc. | 2017-07-27 |
| ATG/SM-OSA APPLIANCES (K130130) | Selane Products, Inc. | 2013-08-26 |
| MILLENIUM ANTI-SNORING DEVICE (K112627) | Millenium Dental Laboratory, Inc. | 2012-06-06 |
| SNORKEL (K112766) | Fellmar Company | 2012-06-04 |
| NARVAL CC (K113201) | Resmed Sas | 2011-12-01 |
| IST SNORING APPLIANCE (K090911) | Dental Crafters | 2009-09-11 |
| FULL BREATH SLEEP APPLIANCE LOWER (FBSL) (K091035) | Bryan Keropian Dds | 2009-06-24 |
Recalls involving this device
No recalls on record reference this clearance.