510(k) K921601
K921601 is an FDA 510(k) premarket notification submitted by Ultradent Products, Inc. for the device "ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE". The FDA issued a decision of Substantially Equivalent on June 16, 1992. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Ultradent Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 1992
- Date Received
- April 3, 1992
- 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