FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DUO TWO LAYER DENTURE CLEANSER
K Number: K791064
·
Decision Oct 9, 1979
Classifications
1
FEI Numbers
126
Registration Numbers
127
Same Product Code
25
Applicant Total
10
Review Days
120
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Basic Information
- Device Name
- DUO TWO LAYER DENTURE CLEANSER
- K Number
- K791064
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3520
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Block Drug Company, Inc.
- Date Received
- June 11, 1979
- Decision Date
- October 9, 1979
- 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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Other Clearances by Block Drug Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945462 | SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Dec 20, 1994 | Substantially Equivalent |
| K935925 | VISION PROPHY PASTE WITH FLUORIDE | Jan 26, 1994 | Substantially Equivalent |
| K933893 | VISION PROPHY PASTE WITHOUT FLUORIDE | Nov 16, 1993 | Substantially Equivalent |
| K884533 | SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM | Apr 12, 1989 | Substantially Equivalent |
| K881974 | PROFICIENT(TM) PROPHYLAXIS ANGLE | Jul 25, 1988 | Substantially Equivalent |
| K872225 | SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER | Jun 30, 1987 | Substantially Equivalent |
| K862876 | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Aug 29, 1986 | Substantially Equivalent |
| K800831 | PY-CO-PROX TM DENTAL BRUSH | May 8, 1980 | Substantially Equivalent |
| K780849 | DENTROL LIQUID DENTURE ADHESIVE | Jul 31, 1978 | Substantially Equivalent |