Premier Promax Bite Guard
FDA 510(k) K941856 · Premier Dental Products Co.
510(k) numberK941856
Submission
- Device name
- Premier Promax Bite Guard
- Applicant
- Premier Dental Products Co.
Philadelphia, PA, US - Received
- April 15, 1994
- Decision date
- April 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K992269 | Ventil-A Oral ProtectorJXL · Traditional | Somatics, Inc. | 10/25/1999SE |
| K960663 | Universal Bite BlockJXL · Traditional | B&B Medical Technologies, Inc. | 05/17/1996SE |
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| K924333 | The Davis Disposable Protective SplintJXL · Traditional | Ora-Gard, Inc. | 04/23/1993SE |
| K924304 | Bite BlockJXL · Traditional | United States Endoscopy Group, Inc. | 04/06/1993SE |
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| K062683 | Enamel Pro VarnishLBH · Traditional | 11/21/2006SE |
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Questions and answers
When was Premier Promax Bite Guard cleared by the FDA?
Premier Promax Bite Guard (K941856) received a 510(k) decision of Substantially Equivalent on April 5, 1995, 355 days after the submission was received.
What is the product code of K941856?
The FDA product code is JXL – Block, Bite, a Class II (moderate risk) device regulated under 21 CFR 882.5070.