510(k) K110037
K110037 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, LLC for the device "PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID". The FDA issued a decision of Substantially Equivalent on April 29, 2011. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Heraeus Kulzer, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2011
- Date Received
- January 6, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type