FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
K Number: K974761
·
Decision Jun 16, 1998
Classifications
1
FEI Numbers
573
Registration Numbers
574
Same Product Code
48
Applicant Total
4
Review Days
179
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Basic Information
- Device Name
- BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
- K Number
- K974761
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- John O. Butler Co.
- Date Received
- December 19, 1997
- Decision Date
- June 16, 1998
- 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 |
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