510(k) K123215
K123215 is an FDA 510(k) premarket notification submitted by Ultradent Products, Inc. for the device "VISCOSTAT CLEAR". The FDA issued a decision of Substantially Equivalent on February 5, 2013. 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
- February 5, 2013
- Date Received
- October 15, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cord, Retraction
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type