GC BLUE SILICONE— 510(k) K120521
Substantially EquivalentGC America, Inc.
FDA 510(k) clearance K120521 for GC BLUE SILICONE, Substantially Equivalent on 2012-05-10. Applicant: GC America, Inc.. Device class: 2.
Clearance details
- Applicant
- GC America, Inc.
- Product code
- Code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alsip, IL, US
Recent devices under product code ELW
view all- K254112 — Dia-X Sil Bite
- K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more
- K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
- K241924 — Elastic Impression Material
- K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
More clearances from GC America, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.