FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAL FLOSS
K Number: K913087
·
Decision Sep 30, 1991
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
3
Review Days
80
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Basic Information
- Device Name
- DENTAL FLOSS
- K Number
- K913087
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Westone Products , Ltd.
- Date Received
- July 12, 1991
- Decision Date
- September 30, 1991
- Product Code
- JES
- 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 |
|---|---|---|---|
| JES | Floss, Dental | FDA class 1 | Dental |
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