CONICAL CONNECTION IMPLANTS— 510(k) K112162
Substantially EquivalentMis Implants Technologies , Ltd.
FDA 510(k) clearance K112162 for CONICAL CONNECTION IMPLANTS, Substantially Equivalent on 2012-08-08. Applicant: Mis Implants Technologies , Ltd.. Device class: 2.
Clearance details
- Applicant
- Mis Implants Technologies , Ltd.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bar Lev Industrial Park, IL
Recent devices under product code DZE
view allMore clearances from Mis Implants Technologies , Ltd.
view all- K182228 — MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
- K180282 — MIS Internal Hex Dental Implant System
- K173326 — MIS CONNECT Conical Connection Abutment
- K172505 — MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
- K163349 — MIS V3 Conical Connection Dental Implant System
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.