SRGC-06— 510(k) K261246
Substantially EquivalentGC America, Inc.
FDA 510(k) clearance K261246 for SRGC-06, Substantially Equivalent on 2026-06-18. Applicant: GC America, Inc.. Device class: 2.
Summary
SRGC-06 from GC America is filed under EBF, resin tooth shade materials. The record doesn't explain the name or describe the material beyond the code name.
Class II, 21 CFR 872.3690. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
GC America filed from Alsip, Illinois. The decision came 63 calendar days after FDA received it (April 16 to June 18, 2026).
Clearance details
- Applicant
- GC America, Inc.
- Product code
- Product code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alsip, IL, US
Recent devices under product code EBF
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