510(k) K112186
K112186 is an FDA 510(k) premarket notification submitted by Bioloren S.R.L. for the device "FIBER DISK AND BLOCK". The FDA issued a decision of Substantially Equivalent on Nov 8, 2011. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Bioloren S.R.L. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 8, 2011
- Date Received
- Jul 29, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type
- 510(k)