FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROFAST(R)-DENTURE CLEANSER
K Number: K930337
·
Decision Sep 7, 1993
Classifications
1
FEI Numbers
126
Registration Numbers
127
Same Product Code
25
Applicant Total
3
Review Days
228
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Basic Information
- Device Name
- PROFAST(R)-DENTURE CLEANSER
- K Number
- K930337
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3520
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fittydent-Altwirth & Schmitt GmbH
- Date Received
- January 22, 1993
- Decision Date
- September 7, 1993
- Product Code
- EFT
- 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 |
|---|---|---|---|
| EFT | Cleanser, Denture, Over The Counter | FDA class 1 | Dental |
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