FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORALCHEK SUPER-SOFT BRUSH
K Number: K892264
·
Decision Jun 14, 1989
Classifications
1
FEI Numbers
573
Registration Numbers
574
Same Product Code
48
Applicant Total
30
Review Days
70
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Basic Information
- Device Name
- ORALCHEK SUPER-SOFT BRUSH
- K Number
- K892264
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pfizer, Inc.
- Date Received
- April 5, 1989
- Decision Date
- June 14, 1989
- 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
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ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
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MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
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