FDA 510(k)
FDA class 2
Substantially Equivalent
🇿🇦 South Africa
Zygomatic Implant System
K Number: K173343
·
Decision Feb 27, 2018
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
19
Review Days
126
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Basic Information
- Device Name
- Zygomatic Implant System
- K Number
- K173343
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Southern Implants (Pty), Ltd.
- Date Received
- October 24, 2017
- Decision Date
- February 27, 2018
- 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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|---|---|---|---|
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| K222469 | TIB Abutments | Apr 17, 2023 | Substantially Equivalent |
| K222457 | Provata Implant System | Mar 6, 2023 | Substantially Equivalent |
| K222497 | Zaga Zygomatic System | Nov 9, 2022 | Substantially Equivalent |
| K210923 | Southern Implants Instrument Trays | Mar 2, 2022 | Substantially Equivalent |
| K193084 | TIB Abutment System | Oct 27, 2020 | Substantially Equivalent |
| K192651 | ZAGA Zygomatic System | May 7, 2020 | Substantially Equivalent |
| K191054 | Southern Implants MAX Implant System | Dec 9, 2019 | Substantially Equivalent |