FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SULZER DENTAL CERAMIC SYSTEM-HEXLOCK
K Number: K014175
·
Decision Mar 20, 2002
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
9
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SULZER DENTAL CERAMIC SYSTEM-HEXLOCK
- K Number
- K014175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sulzer Dental, Inc.
- Date Received
- December 20, 2001
- Decision Date
- March 20, 2002
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.
Neodent Scannable Healing Abutment
FDA 510(k)
FDA Class 2
·Dental
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)
FDA 510(k)
FDA Class 2
·Dental
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
SIC Abutments including CAD/CAM Solutions
FDA 510(k)
FDA Class 2
·Dental
Elos Accurate® Denture Fixation System
FDA 510(k)
FDA Class 2
·Dental
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Sulzer Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K014050 | HEX-LOCK TEMPORARY ABUTMENT | Nov 13, 2002 | Substantially Equivalent |
| K014214 | SULZER DENTAL CERAMIC SYSTEM-SPLINE | Mar 19, 2002 | Substantially Equivalent |
| K013494 | 3.75MM AND 5.0MM SPLINE TWIST IMPLANT | Jan 18, 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 |