FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
K Number: K935443
·
Decision Sep 20, 1994
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
3
Review Days
312
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Basic Information
- Device Name
- ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
- K Number
- K935443
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osada Electric Co., Ltd.
- Date Received
- November 12, 1993
- Decision Date
- September 20, 1994
- Product Code
- DZH
- 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 |
|---|---|---|---|
| DZH | Saw, Bone, Ac-Powered | FDA class 2 | Dental |
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