FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KOLYNOS DENTAL FLOSS
K Number: K882571
·
Decision Oct 12, 1988
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
2
Review Days
112
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Basic Information
- Device Name
- KOLYNOS DENTAL FLOSS
- K Number
- K882571
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Whitehall Laboratories, Inc.
- Date Received
- June 22, 1988
- Decision Date
- October 12, 1988
- 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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IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
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JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS
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Other Clearances by Whitehall Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882572 | DOCTOR KOLYNOS TOOTHBRUSH | Apr 17, 1989 | Substantially Equivalent |