510(k) K172761
K172761 is an FDA 510(k) premarket notification submitted by Shanghai New Century Dental Materials Co., Ltd. for the device "New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)". The FDA issued a decision of Substantially Equivalent on Nov 17, 2017. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 17, 2017
- Date Received
- Sep 13, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type
- 510(k)