510(k) K150696
K150696 is an FDA 510(k) premarket notification submitted by Dharma Research, Inc. for the device "Jade 37% Phosphoric Acid Etchant Gel". The FDA issued a decision of Substantially Equivalent on June 23, 2015. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2015
- Date Received
- March 18, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type