FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
K Number: K945200
·
Decision Nov 30, 1994
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
3
Applicant Total
23
Review Days
36
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Basic Information
- Device Name
- FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
- K Number
- K945200
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3490
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Procter & Gamble Co.
- Date Received
- October 25, 1994
- Decision Date
- November 30, 1994
- Product Code
- KOO
- 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 |
|---|---|---|---|
| KOO | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOO), ordered by most recent decision date.
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NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM
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