FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED
K Number: K133339
·
Decision Mar 4, 2014
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
40
Review Days
125
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Basic Information
- Device Name
- ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED
- K Number
- K133339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zimmer Dental, Inc.
- Date Received
- October 30, 2013
- Decision Date
- March 4, 2014
- 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 Zimmer Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160398 | MRI Compatibility for Existing Zimmer Dental Implant Systems | May 17, 2017 | Substantially Equivalent |
| K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | Jun 25, 2015 | Substantially Equivalent |
| K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System | May 1, 2015 | Substantially Equivalent |
| K142572 | Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System | Jan 21, 2015 | Substantially Equivalent |
| K142082 | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT | Oct 28, 2014 | Substantially Equivalent |
| K141544 | ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM | Oct 22, 2014 | Substantially Equivalent |
| K141120 | ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM | Jul 29, 2014 | Substantially Equivalent |
| K133551 | ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM | Jul 18, 2014 | Substantially Equivalent |
| K134045 | ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM | Apr 25, 2014 | Substantially Equivalent |
| K132258 | ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM | Nov 19, 2013 | Substantially Equivalent |