FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER ORAL MAX SYSTEM
K Number: K954690
·
Decision Aug 20, 1996
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
124
Review Days
314
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Basic Information
- Device Name
- STRYKER ORAL MAX SYSTEM
- K Number
- K954690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corp.
- Date Received
- October 11, 1995
- Decision Date
- August 20, 1996
- Product Code
- DZI
- 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 |
|---|---|---|---|
| DZI | Drill, Bone, Powered | FDA class 2 | Dental |
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