FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTURE CLEANSER
K Number: K841801
·
Decision Jun 22, 1984
Classifications
1
FEI Numbers
126
Registration Numbers
127
Same Product Code
25
Applicant Total
1
Review Days
52
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Basic Information
- Device Name
- DENTURE CLEANSER
- K Number
- K841801
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3520
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Miracle Clean, Inc.
- Date Received
- May 1, 1984
- Decision Date
- June 22, 1984
- 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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