510(k) K071615
K071615 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties, Inc. for the device "FIXAFLOSS". The FDA issued a decision of Substantially Equivalent on September 21, 2007. The device falls under product code EEF (Clamp, Rubber Dam), a Class I device regulated under 21 CFR 872.6300. Sybron Dental Specialties, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2007
- Date Received
- June 13, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Rubber Dam
- Device Class
- Class I
- Regulation Number
- 872.6300
- Review Panel
- DE
- Submission Type