FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Z5-BL
K Number: K190243
·
Decision Jan 3, 2020
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
9
Review Days
331
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Basic Information
- Device Name
- Z5-BL
- K Number
- K190243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Z-Systems AG
- Date Received
- February 6, 2019
- Decision Date
- January 3, 2020
- 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 Z-Systems AG
| K Number | Device Name | ||
|---|---|---|---|
| K201878 | ST-Z5 | Mar 25, 2021 | Substantially Equivalent |
| K201712 | Z5-TL | Dec 1, 2020 | Substantially Equivalent |
| K200386 | Z5-BL | Oct 14, 2020 | Substantially Equivalent |
| K150021 | Z5m(t) | Jul 31, 2015 | Substantially Equivalent |
| K132881 | Z5C | Jul 3, 2014 | Substantially Equivalent |
| K131701 | Z5MLB, Z5MLC | Sep 5, 2013 | Substantially Equivalent |
| K120793 | Z-LOOK3 EVO SLM | Dec 21, 2012 | Substantially Equivalent |
| K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX | Oct 29, 2007 | Substantially Equivalent |