FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GC FUJI COAT LC
K Number: K935961
·
Decision Mar 10, 1994
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
410
Applicant Total
98
Review Days
87
Basic Information
- Device Name
- GC FUJI COAT LC
- K Number
- K935961
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GC AMERICA, INC.
- Date Received
- December 13, 1993
- Decision Date
- March 10, 1994
- Product Code
- KLE
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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| K123631 | MFP-051 | Jul 23, 2013 | Substantially Equivalent |
| K113816 | GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV | Jan 30, 2013 | Substantially Equivalent |
| K120521 | GC BLUE SILICONE | May 10, 2012 | Substantially Equivalent |
| K103234 | GC AADVA BO AC ABUTMENTS | Jun 30, 2011 | Substantially Equivalent |