510(k) K941856
K941856 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "PREMIER PROMAX BITE GUARD". The FDA issued a decision of Substantially Equivalent on April 5, 1995. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1995
- Date Received
- April 15, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Bite
- Device Class
- Class II
- Regulation Number
- 882.5070
- Review Panel
- NE
- Submission Type