510(k) K083695
K083695 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "TRAXODENT". The FDA issued a decision of Substantially Equivalent on April 28, 2009. The device falls under product code MVL (Cord, Retraction), a Class U device. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2009
- Date Received
- December 15, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cord, Retraction
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type