510(k) K182854
K182854 is an FDA 510(k) premarket notification submitted by GC America, Inc. for the device "GC FujiCEM 2 (Improved)". The FDA issued a decision of Substantially Equivalent on July 11, 2019. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. GC America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2019
- Date Received
- October 10, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type