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Anthogyr INTEGRAL Guided Surgery Cassettes

by anthogyr

510(k) K233264

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233264↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK233264 Date22 Dec 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233264 decided 22 Dec 2023 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
KCT
Device class
Class II
Regulation
21 CFR Part 880.6850
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Anthogyr INTEGRAL Guided Surgery Cassettes are surgical guides designed for dental implant procedures. These cassettes facilitate precise, computer-assisted implant placement by integrating with digital planning software, ensuring accurate alignment and positioning of dental implants in the patient’s jawbone.

Supplied as single-use, sterile cassettes, these devices are intended for use in general hospital or dental clinic settings. They are compatible with various implant systems and software platforms, allowing clinicians to select configurations tailored to their workflow. Authorised under FDA 510K and MDR, the cassettes adhere to regulatory standards for guided surgical implants.

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