510(k) K172683
K172683 is an FDA 510(k) premarket notification submitted by YAMAHACHI DENTAL MFG., Co. for the device "Yamahachi Pink CAD/CAM Disk". The FDA issued a decision of Substantially Equivalent on January 16, 2018. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. YAMAHACHI DENTAL MFG., Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2018
- Date Received
- September 6, 2017
- 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