FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOR Implant System
K Number: K153173
·
Decision Feb 5, 2016
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
12
Review Days
94
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Basic Information
- Device Name
- MOR Implant System
- K Number
- K153173
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterngold Dental, LLC
- Date Received
- November 3, 2015
- Decision Date
- February 5, 2016
- 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 Sterngold Dental, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | Sep 28, 2017 | Substantially Equivalent |
| K151928 | PUR Dental Implant System | Nov 6, 2015 | Substantially Equivalent |
| K150968 | TRU Dental Implant System | Jul 24, 2015 | Substantially Equivalent |
| K150250 | SternSnap Angled Attachment | Jun 11, 2015 | Substantially Equivalent |
| K142667 | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm | Jan 7, 2015 | Substantially Equivalent |
| K142407 | Straight Stud Attachment | Dec 24, 2014 | Substantially Equivalent |
| K133791 | ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] | Apr 16, 2014 | Substantially Equivalent |
| K132814 | SFI-BAR IMPLANT ABUTMENTS | Feb 25, 2014 | Substantially Equivalent |
| K130183 | SFI BAR ABUTMENTS | Jul 7, 2013 | Substantially Equivalent |
| K130408 | ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT | Jul 1, 2013 | Substantially Equivalent |