FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOOTH SHADE RESIN
K Number: K895976
·
Decision Dec 22, 1989
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
23
Review Days
71
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Basic Information
- Device Name
- TOOTH SHADE RESIN
- K Number
- K895976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- G-C Intl. Corp.
- Date Received
- October 12, 1989
- Decision Date
- December 22, 1989
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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|---|---|---|---|
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| K892806 | TUF-COAT | Jul 14, 1989 | Substantially Equivalent |
| K890830 | DENTURE RESIN | May 1, 1989 | Substantially Equivalent |
| K890829 | UNIFAST LC | Apr 17, 1989 | Substantially Equivalent |
| K883770 | RESUBMITTED EMA DENTIN CEMENT | Nov 30, 1988 | Substantially Equivalent |
| K880848 | FUJI CAP II CAPSULE & APPLIER | May 16, 1988 | Substantially Equivalent |