510(k) K193484
K193484 is an FDA 510(k) premarket notification submitted by GC America, Inc. for the device "GC Fuji Triage EP". The FDA issued a decision of Substantially Equivalent on July 2, 2020. 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 2, 2020
- Date Received
- December 17, 2019
- 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