510(k) K133088
K133088 is an FDA 510(k) premarket notification submitted by M&M Dental Studio, Inc. for the device "ZX-27". The FDA issued a decision of Substantially Equivalent on January 2, 2015. The device falls under product code EJX (Anchor, Preformed), a Class I device regulated under 21 CFR 872.3130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 2015
- Date Received
- September 30, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anchor, Preformed
- Device Class
- Class I
- Regulation Number
- 872.3130
- Review Panel
- DE
- Submission Type