FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORAL-B ULTRAFLOSS WITH FLLUORIDE
K Number: K943157
·
Decision Apr 27, 1995
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
8
Review Days
300
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Basic Information
- Device Name
- ORAL-B ULTRAFLOSS WITH FLLUORIDE
- K Number
- K943157
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oral-B Laboratories
- Date Received
- July 1, 1994
- Decision Date
- April 27, 1995
- 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 Oral-B Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K942633 | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE | Apr 27, 1995 | Substantially Equivalent |
| K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Sep 9, 1994 | Substantially Equivalent |
| K932990 | ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP | Sep 29, 1993 | Substantially Equivalent |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Jan 28, 1993 | Substantially Equivalent |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | Jan 28, 1993 | Substantially Equivalent |
| K913603 | FIBRETWINS | Sep 30, 1991 | Substantially Equivalent |
| K883024 | ORAL-B FLOSSERS | Aug 26, 1988 | Substantially Equivalent |