FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED
K Number: K935440
·
Decision Feb 3, 1994
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
8
Review Days
83
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Basic Information
- Device Name
- JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED
- K Number
- K935440
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johnson & Johnson Consumer Products, Inc.
- Date Received
- November 12, 1993
- Decision Date
- February 3, 1994
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Aug 14, 2007 | Substantially Equivalent |
| K943314 | ADHESIVE BANDAGES WITH OTC DRUG | Jan 17, 1996 | Substantially Equivalent |
| K954007 | PARALLEL | Nov 22, 1995 | Substantially Equivalent |
| K951917 | JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS | May 10, 1995 | Substantially Equivalent |
| K941788 | BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP | Oct 3, 1994 | Substantially Equivalent |
| K940536 | BAND-AID(TM) BRAND ADHESIVE BANDAGE | Oct 3, 1994 | Substantially Equivalent |
| K840679 | SERENITY CONTOURED ABSORBENT SHIELDS | Mar 22, 1984 | Substantially Equivalent |