FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BC 1203 ABUTMENT TAPERED SHOULDER
K Number: K904704
·
Decision Mar 21, 1991
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
34
Review Days
156
Basic Information
- Device Name
- BC 1203 ABUTMENT TAPERED SHOULDER
- K Number
- K904704
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- MINIMATIC IMPLANT TECHNOLOGY
- Date Received
- October 16, 1990
- Decision Date
- March 21, 1991
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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