510(k) K941856
- Device
- PREMIER PROMAX BITE GUARD
- Applicant
- PREMIER DENTAL PRODUCTS CO.
- 510(k) number
- K941856
- Product code
- JXL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-05
- Date received
- 1994-04-15
- Regulation
- 882.5070
- Classification name
- Block, Bite
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM J FREZEL
- Address
- 10090 Sandmeyer Ln. Philadelphia PA US 19116 19116
FDA Registration Numbers#
- 3016603542
- 3005998497
- 2428983
- 1924066
- 1314417
- 3015337364
- 3009097913
- 3042640302
- 3023869663
- 3011137372
- 3035479692
- 3004365956
- 1420295
- 3015146495
Source Documents#
Other 510(k) Records For Product Code JXL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221469 | PATI (Protector Against Tongue Injury) | Neurovice, LLC | 2023-02-22 |
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | Mecta Corporation | 2021-06-04 |
| K172978 | SurgeoBite | Surgovations, LLC | 2017-12-22 |
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm | Dupaco, Inc. | 2015-06-29 |
| K050188 | EPIGUARD | Episafe Medical Devices, Ltd. | 2005-04-27 |
| K992269 | VENTIL-A ORAL PROTECTOR | Somatics, Inc. | 1999-10-25 |
| K960663 | UNIVERSAL BITE BLOCK | B&B Medical Technologies, Inc. | 1996-05-17 |
| K954352 | BITE BLOCK | United States Endoscopy Group, Inc. | 1996-01-25 |
| K924333 | THE DAVIS DISPOSABLE PROTECTIVE SPLINT | Ora-Gard, Inc. | 1993-04-23 |
| K924304 | BITE BLOCK | United States Endoscopy Group, Inc. | 1993-04-06 |
| K921946 | TUM-E-VAC BITE BLOCK | Ethox Corp. | 1992-12-09 |
| K901563 | MOUTHPIECE BREATHING | Scott All-Sports, Inc. | 1990-06-28 |
| K896745 | JAW BLOCKER | Plastic Engineered Products Co. | 1989-12-14 |
| K890567 | BITE BLOCK #59430 | Medi-Source, Inc. | 1989-02-17 |
| K883416 | MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) | Scott All-Sports, Inc. | 1988-10-12 |
Legacy Summary#
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FDA Review#
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