FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOMINION
K Number: K831098
·
Decision Jun 16, 1983
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
23
Review Days
73
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Basic Information
- Device Name
- DOMINION
- K Number
- K831098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Unitek Corp.
- Date Received
- April 4, 1983
- Decision Date
- June 16, 1983
- 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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FDA 510(k)
FDA Class 2
·Dental
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| K911271 | ADHESIVE PRECOATED BRACKETS | May 29, 1991 | Substantially Equivalent |
| K910288 | NONSTAINING ALASTIKS | Mar 29, 1991 | Substantially Equivalent |
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