510(k) K152064
K152064 is an FDA 510(k) premarket notification submitted by Ultradent Products, Inc. for the device "Astringedent Clear". The FDA issued a decision of Substantially Equivalent on September 24, 2015. The device falls under product code MVL (Cord, Retraction), a Class U device. Ultradent Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2015
- Date Received
- July 24, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cord, Retraction
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type