Z5-Bl
510(k) K190243
Z5-Bl is a Class II device made by Z-Systems AG, cleared under FDA 510(k) K190243 on 3 Jan 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190243 | Date3 Jan 2020 | StatusActive |
Official records
- FDA 510(k) database K190243
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DZE
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K190243
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BL-OSC-H | BL-OSC-H / BL-OSC-H | 07640166760870 | — | On the market |
| BL-OST | BL-OST / BL-OST | 07640166760863 | — | On the market |
| BL-OST-H | BL-OST-H / BL-OST-H | 07640166764700 | — | On the market |
| Z5-BL-4008 | Z5-BL-4008 / Z5-BL-4008 | 07640166760801 | Length 8 mm; Outer Diameter 4 mm | On the market |
| Z5-BL-4010 | Z5-BL-4010 / Z5-BL-4010 | 07640166760818 | Length 10 mm; Outer Diameter 4 mm | On the market |
| Z5-BL-4012 | Z5-BL-4012 / Z5-BL-4012 | 07640166760825 | Length 12 mm; Outer Diameter 4 mm | On the market |
| Z5-BL-5008 | Z5-BL-5008 / Z5-BL-5008 | 07640166760832 | Length 8 mm; Outer Diameter 5 mm | On the market |
| Z5-BL-5010 | Z5-BL-5010 / Z5-BL-5010 | 07640166760849 | Length 10 mm; Outer Diameter 5 mm | On the market |
| Z5-BL-5012 | Z5-BL-5012 / Z5-BL-5012 | 07640166760856 | Length 12 mm; Outer Diameter 5 mm | On the market |
Similar devices
Other devices filed under FDA product code DZE (Implant, Endosseous, Root-Form).
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- MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS by Implant Innovations, Inc.
- S.I.N. Implant System by S.I.N. - Sistema DE Implante Nacional S.A.
- KONTACT S K5010-42S by BIOTECH DENTAL
- UV Active Implant System by DIO Corporation