FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BIOPORTA G, MODEL 2052
K Number: K012826
·
Decision Nov 1, 2001
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
14
Review Days
70
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Basic Information
- Device Name
- BIOPORTA G, MODEL 2052
- K Number
- K012826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wieland Edelmetalle GmbH & Co.
- Date Received
- August 23, 2001
- Decision Date
- November 1, 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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|---|---|---|---|
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| K012828 | PORTA SMK 82, MODEL 2032 | Nov 1, 2001 | Substantially Equivalent |
| K012834 | PORTA GEO TI MODEL #2004 | Nov 1, 2001 | Substantially Equivalent |
| K012831 | BIO PORTADUR, ORDER-NO.:2017 | Nov 1, 2001 | Substantially Equivalent |
| K012827 | PORTA AURIUM, MODEL 2067 | Nov 1, 2001 | Substantially Equivalent |
| K012835 | PORTA MAXIMUM, MODEL# 2066 | Nov 1, 2001 | Substantially Equivalent |
| K012838 | ERO50, ORDER-NO.: 2070 | Oct 23, 2001 | Substantially Equivalent |