FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPREMCAST
K Number: K011705
·
Decision Aug 3, 2001
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
5
Review Days
60
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Basic Information
- Device Name
- SUPREMCAST
- K Number
- K011705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Dent-All, Inc.
- Date Received
- June 4, 2001
- Decision Date
- August 3, 2001
- Product Code
- EJH
- 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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | FDA class 2 | Dental |
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