FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METAFIL
K Number: K923867
·
Decision Oct 6, 1992
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
8
Review Days
64
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Basic Information
- Device Name
- METAFIL
- K Number
- K923867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Parkell
- Date Received
- August 3, 1992
- Decision Date
- October 6, 1992
- 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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|---|---|---|---|
| K905032 | MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL | Mar 15, 1991 | Substantially Equivalent |
| K900303 | CONNECT | Apr 12, 1990 | Substantially Equivalent |
| K896719 | PRIMER-P ADHESIVE AGENT | Feb 22, 1990 | Substantially Equivalent |
| K895750 | HEMA-PRIMER | Dec 21, 1989 | Substantially Equivalent |
| K892003 | ABRAKADABRA - DENTAL ADHESIVE SYSTEM | Jun 7, 1989 | Substantially Equivalent |
| K884918 | PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER | Feb 13, 1989 | Substantially Equivalent |
| K881914 | COVER UP | Jul 15, 1988 | Substantially Equivalent |