FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
K Number: K963746
·
Decision Dec 12, 1996
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
2
Review Days
86
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Basic Information
- Device Name
- IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
- K Number
- K963746
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Whitehill Oral Technologies, Inc.
- Date Received
- September 17, 1996
- Decision Date
- December 12, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JES), ordered by most recent decision date.
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
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FLOSSBRUSH WITH FLUORIDE
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PERIO-MED DENTAL FLOSS
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VUTLER G.U.M. WITH FLUORIDE
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JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS
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RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE
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Other Clearances by Whitehill Oral Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944034 | PERIO-MED DENTAL FLOSS | Jul 25, 1995 | Substantially Equivalent |