SOMNOBRUX SPLINTS
FDA 510(k) clearance K102909 · decided 2011-12-13
Clearance details
- K-number
- K102909
- Device name
- SOMNOBRUX SPLINTS
- Applicant
- Somnomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-01
- Decision date
- 2011-12-13
- Days to decision
- 438 days
- Clearance type
- Traditional
- Product code
- MQC
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Frisco, TX, 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.
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|---|---|---|
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| GR Resin System MSI (K231775) | Pro3Dure Medical | 2024-08-08 |
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| Slow Wave DS8 (SWDS802) (K240463) | Slow Wave, Inc. | 2024-06-04 |
| RODIN 3D Resin SPLINT, Hard/Flex (K231793) | Belport Company, Inc., Gingi-Pak | 2024-03-26 |
| Dental LT Comfort Resin (K232087) | Formlabs Ohio, Inc. | 2024-02-16 |
| Myoaligner Appliance (K230548) | Myohealth Technologies, LLC | 2024-02-02 |
Recalls involving this device
No recalls on record reference this clearance.