FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP
K Number: K932990
·
Decision Sep 29, 1993
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
8
Review Days
103
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Basic Information
- Device Name
- ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP
- K Number
- K932990
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oral-B Laboratories
- Date Received
- June 18, 1993
- Decision Date
- September 29, 1993
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, 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 |
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | Apr 27, 1995 | Substantially Equivalent |
| K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Sep 9, 1994 | 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 |