510(k) K133836
K133836 is an FDA 510(k) premarket notification submitted by GC America, Inc. for the device "OPTIGLAZE COLOR". The FDA issued a decision of Substantially Equivalent on March 6, 2014. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. GC America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2014
- Date Received
- December 18, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type