FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORCELAIN PRIMER
K Number: K920534
·
Decision Mar 26, 1992
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
31
Review Days
50
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Basic Information
- Device Name
- PORCELAIN PRIMER
- K Number
- K920534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Confi-Dental Products Co.
- Date Received
- February 5, 1992
- Decision Date
- March 26, 1992
- Product Code
- DYH
- 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
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Other Clearances by Confi-Dental Products Co.
| K Number | Device Name | ||
|---|---|---|---|
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| K954988 | CRYSTALLESSENCE | Mar 8, 1996 | Substantially Equivalent |
| K952930 | DENTRAY II PLUS TRAY ADHESIVE | Sep 8, 1995 | Substantially Equivalent |
| K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Jan 26, 1995 | Substantially Equivalent |
| K940546 | GRANITEC IONOMER RESIN CEMENT | Apr 29, 1994 | Substantially Equivalent |
| K936070 | TREND SET 2 PLUS | Feb 4, 1994 | Substantially Equivalent |
| K935714 | CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Jan 21, 1994 | Substantially Equivalent |