FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RD-3008
K Number: K011036
·
Decision May 10, 2001
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
626
Applicant Total
145
Review Days
35
Basic Information
- Device Name
- RD-3008
- K Number
- K011036
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HERAEUS KULZER, INC.
- Date Received
- April 5, 2001
- Decision Date
- May 10, 2001
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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