FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL
K Number: K920460
·
Decision Apr 28, 1992
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
78
Review Days
92
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Basic Information
- Device Name
- 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL
- K Number
- K920460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pulpdent Corp.
- Date Received
- January 27, 1992
- Decision Date
- April 28, 1992
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, Porcelain | FDA class 2 | Dental |
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|---|---|---|---|
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| K994180 | PULPDENT CAVITY PREPARATION III | Mar 2, 2000 | Substantially Equivalent |
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| K994182 | PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE | Feb 23, 2000 | Substantially Equivalent |
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