FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORAFIX SPECIAL DENTURE ADHESIVE
K Number: K943486
·
Decision Nov 3, 1994
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
3
Applicant Total
1
Review Days
107
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Basic Information
- Device Name
- ORAFIX SPECIAL DENTURE ADHESIVE
- K Number
- K943486
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3490
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Smithkline Beecham Corp.
- Date Received
- July 19, 1994
- Decision Date
- November 3, 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 |
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