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Ankylos C/X Implant System

by Dentsply Intl., Inc.

510(k) K140347

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

For dental implants, the ANKYLOS C/X IMPLANT SYSTEM offers a revolutionary alternative to traditional implants. This innovative device combines the benefits of bioceramic materials with advanced bone-anchoring technology, providing unparalleled stability and longevity. With its unique design and proprietary coating, the ANKYLOS C/X system is designed to reduce healing time and improve patient outcomes.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140347 Date20 Aug 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

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