FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIBER OPTICS HIGH SPEED HANDPIECE
K Number: K760794
·
Decision Oct 20, 1976
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
13
Review Days
12
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Basic Information
- Device Name
- FIBER OPTICS HIGH SPEED HANDPIECE
- K Number
- K760794
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Midwest
- Date Received
- October 8, 1976
- Decision Date
- October 20, 1976
- 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 Midwest
| K Number | Device Name | ||
|---|---|---|---|
| K863677 | TRADITION HIGH SPEED HANDPIECE | Oct 6, 1986 | Substantially Equivalent |
| K850344 | AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG | Mar 25, 1985 | Substantially Equivalent |
| K792445 | MW STRAIGHT ATTACHMENT | Dec 6, 1979 | Substantially Equivalent |
| K792304 | MW-8000 | Nov 27, 1979 | Substantially Equivalent |
| K792302 | LS-100 | Nov 27, 1979 | Substantially Equivalent |
| K792303 | MW 8000-I | Nov 27, 1979 | Substantially Equivalent |
| K791771 | ORALUMINATOR III AUTO-LIGHT | Nov 20, 1979 | Substantially Equivalent |
| K791733 | LIGHT-PAK | Oct 23, 1979 | Substantially Equivalent |
| K790113 | MIDWEST 1000 | Feb 26, 1979 | Substantially Equivalent |
| K781878 | LIGHT, INSIDE | Dec 29, 1978 | Substantially Equivalent |