FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSLUX ENERGY
K Number: K012341
·
Decision Aug 30, 2001
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
145
Review Days
37
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Basic Information
- Device Name
- TRANSLUX ENERGY
- K Number
- K012341
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- July 24, 2001
- Decision Date
- August 30, 2001
- Product Code
- EBZ
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |