FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PY-CO-PROX TM DENTAL BRUSH
K Number: K800831
·
Decision May 8, 1980
Classifications
1
FEI Numbers
573
Registration Numbers
574
Same Product Code
48
Applicant Total
10
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PY-CO-PROX TM DENTAL BRUSH
- K Number
- K800831
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Block Drug Company, Inc.
- Date Received
- April 14, 1980
- Decision Date
- May 8, 1980
- Product Code
- EFW
- 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 |
|---|---|---|---|
| EFW | Toothbrush, Manual | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFW), ordered by most recent decision date.
DENTEK EASY BRUSH WITH FLUORIDE
FDA 510(k)
FDA Class 1
·Dental
BEAM BRUSH/BEAM APP
FDA 510(k)
FDA Class 1
·Dental
SILVER CARE ANITBACTERIAL TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
FDA 510(k)
FDA Class 1
·Dental
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
FDA 510(k)
FDA Class 1
·Dental
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 |
| K791064 | DUO TWO LAYER DENTURE CLEANSER | Oct 9, 1979 | Substantially Equivalent |
| K780849 | DENTROL LIQUID DENTURE ADHESIVE | Jul 31, 1978 | Substantially Equivalent |