510(k) K111185
K111185 is an FDA 510(k) premarket notification submitted by 3M Espe Dental Products for the device "RELYX LUTING PLUS AUTOMIX". The FDA issued a decision of Substantially Equivalent on May 5, 2011. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. 3M Espe Dental Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2011
- Date Received
- April 27, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type