FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE
K Number: K871393
·
Decision Apr 15, 1987
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
2
Review Days
8
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Basic Information
- Device Name
- DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE
- K Number
- K871393
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Flossrite Corp.
- Date Received
- April 7, 1987
- Decision Date
- April 15, 1987
- 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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Other Clearances by Flossrite Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871392 | DR FLOSSER REFILL | Apr 15, 1987 | Substantially Equivalent |