510(k) K935522
K935522 is an FDA 510(k) premarket notification submitted by Ranir/Dcp Corp. for the device "RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Ranir/Dcp Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1994
- Date Received
- November 16, 1993
- 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