ANKYLOS C/X IMPLANT SYSTEM— 510(k) K140347

Name: FDA 510(k) clearance K140347
Creator: U.S. Food and Drug Administration
Published: 2014-08-20

Substantially Equivalent

Dentsply Intl., Inc.

FDA 510(k) clearance K140347 for ANKYLOS C/X IMPLANT SYSTEM, Substantially Equivalent on 2014-08-20. Applicant: Dentsply Intl., Inc.. Device class: 2.

Clearance details

Applicant: Dentsply Intl., Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2014-02-11
Decision date: 2014-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
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K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Dentsply Intl., Inc.

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K130862 — CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM2013-07-23
K103244 — QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION2011-02-14
K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II2009-10-30
K083805 — ANKYLOS C/X DENTAL IMPLANT SYSTEM2009-05-22
K082198 — DURASHIELD PLUS2008-10-29

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, 2020-01-01 through 2026-04-23. 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.