FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRIGHT GOLD XH
K Number: K041433
·
Decision Aug 19, 2004
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
65
Review Days
83
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Basic Information
- Device Name
- BRIGHT GOLD XH
- K Number
- K041433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ivoclar Vivadent, Inc.
- Date Received
- May 28, 2004
- Decision Date
- August 19, 2004
- Product Code
- EJS
- 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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | FDA class 2 | Dental |
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