510(k) K911701
K911701 is an FDA 510(k) premarket notification submitted by Implant Innovations International, Inc. for the device "G-FLOSS & G-FLOSS II". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Implant Innovations International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1991
- Date Received
- April 16, 1991
- 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