510(k) K791223
K791223 is an FDA 510(k) premarket notification submitted by Den-Mat Corp. for the device "DEN-MAT DENTAL FLOSSER". The FDA issued a decision of Substantially Equivalent on October 9, 1979. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Den-Mat Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1979
- Date Received
- July 3, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Floss, Dental
- Device Class
- Class I
- Regulation Number
- 872.6390
- Review Panel
- DE
- Submission Type