FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XIVE DENTAL IMPLANT SYSTEM MULTIPLE
K Number: K032158
·
Decision Aug 14, 2003
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
18
Review Days
30
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Basic Information
- Device Name
- XIVE DENTAL IMPLANT SYSTEM MULTIPLE
- K Number
- K032158
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Friadent GmbH
- Date Received
- July 15, 2003
- Decision Date
- August 14, 2003
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Friadent GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K040170 | FRIADENT PLUS DENTAL IMPLANT SYSTEMS | Oct 27, 2004 | Substantially Equivalent |
| K041509 | ANKYLOS DENTAL IMPLANT SYSTEM | Aug 26, 2004 | Substantially Equivalent |
| K040946 | ANKYLOS DENTAL IMPLANT SYSTEM | Jul 1, 2004 | Substantially Equivalent |
| K032302 | XIVE TG ABUTMENTS | Oct 2, 2003 | Substantially Equivalent |
| K031674 | MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM | Aug 14, 2003 | Substantially Equivalent |
| K032284 | XIVE TG DENTAL IMPLANT SYSTEM | Aug 14, 2003 | Substantially Equivalent |
| K024004 | XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM | Mar 3, 2003 | Substantially Equivalent |
| K023799 | FRIOS ALGIPORE | Feb 5, 2003 | Substantially Equivalent |
| K021318 | XIVE DENTAL IMPLANT SYSTEM | Jul 2, 2002 | Substantially Equivalent |
| K013067 | FRIALOC DENTAL IMPLANT SYSTEM | Apr 9, 2002 | Substantially Equivalent |