PREMIER PROMAX BITE GUARD
FDA 510(k) clearance K941856 · decided 1995-04-05
Clearance details
- K-number
- K941856
- Device name
- PREMIER PROMAX BITE GUARD
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-04-15
- Decision date
- 1995-04-05
- Days to decision
- 355 days
- Clearance type
- Traditional
- Product code
- JXL
- Device class
- 2
- Regulation number
- 882.5070
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Philadelphia, PA, 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 |
|---|---|---|
| PATI (Protector Against Tongue Injury) (K221469) | Neurovice, LLC | 2023-02-22 |
| ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (K201309) | Mecta Corporation | 2021-06-04 |
| SurgeoBite (K172978) | Surgovations, LLC | 2017-12-22 |
| Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm (K150518) | Dupaco, Inc. | 2015-06-29 |
| EPIGUARD (K050188) | Episafe Medical Devices, Ltd. | 2005-04-27 |
| VENTIL-A ORAL PROTECTOR (K992269) | Somatics, Inc. | 1999-10-25 |
| UNIVERSAL BITE BLOCK (K960663) | B&B Medical Technologies, Inc. | 1996-05-17 |
| BITE BLOCK (K954352) | United States Endoscopy Group, Inc. | 1996-01-25 |
| THE DAVIS DISPOSABLE PROTECTIVE SPLINT (K924333) | Ora-Gard, Inc. | 1993-04-23 |
| BITE BLOCK (K924304) | United States Endoscopy Group, Inc. | 1993-04-06 |
| TUM-E-VAC BITE BLOCK (K921946) | Ethox Corp. | 1992-12-09 |
| MOUTHPIECE BREATHING (K901563) | Scott All-Sports, Inc. | 1990-06-28 |
Recalls involving this device
No recalls on record reference this clearance.