FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3.75MM AND 5.0MM SPLINE TWIST IMPLANT
K Number: K013494
·
Decision Jan 18, 2002
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
9
Review Days
88
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Basic Information
- Device Name
- 3.75MM AND 5.0MM SPLINE TWIST IMPLANT
- K Number
- K013494
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sulzer Dental, Inc.
- Date Received
- October 22, 2001
- Decision Date
- January 18, 2002
- 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 Sulzer Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K014050 | HEX-LOCK TEMPORARY ABUTMENT | Nov 13, 2002 | Substantially Equivalent |
| K014175 | SULZER DENTAL CERAMIC SYSTEM-HEXLOCK | Mar 20, 2002 | Substantially Equivalent |
| K014214 | SULZER DENTAL CERAMIC SYSTEM-SPLINE | Mar 19, 2002 | Substantially Equivalent |
| K013227 | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT | Nov 19, 2001 | Substantially Equivalent |
| K012055 | 3.25MM SPLINE TWIST IMPLANT | Sep 6, 2001 | Substantially Equivalent |
| K011245 | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM | Jun 25, 2001 | Substantially Equivalent |
| K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM | May 21, 2001 | Substantially Equivalent |
| K011038 | TAPER-LOCK DENTAL IMPLANT SYSTEM | May 15, 2001 | Substantially Equivalent |