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Allfit Implant System, Short Neck, Model STI RT Length, Allfit Implant System, Long Neck, Model STI RT LN Length

by Dr. Ihde Dental AG Switzerland

510(k) K991822

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991822 Date15 Aug 2001ClearedStatusActive

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Allfit Implant System is a screw-type endosseous dental implant made of commercially pure CP Titanium Grade 4. It is a soft tissue level implant with an internal connection, designed for functional and aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws when adequate bone supply exists in terms of bone quality, width, and height.

The device is supplied as part of the Allfit Implant System and is compatible with components such as impression copings, implant analogs, abutments, straight multi-unit abutments, scan bodies, titanium bases, locators, locator R-TX, ball attachments, screws, and screwdrivers. It received FDA 510(k) clearance (K991822) under product code DZE and is classified as substantially equivalent to a legally marketed device.

Questions

AI-generated answers, 6 Oct 2026

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

  • What is the Allfit Implant System used for?

    The Allfit Implant System is designed for functional and aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws when adequate bone supply exists in terms of bone quality, width, and height, as it is a soft tissue level implant with an internal connection intended to support prosthetic components for tooth replacement.

  • What material is the Allfit Implant System made of and what type of implant is it?

    The Allfit Implant System is made of commercially pure CP Titanium Grade 4 and is a screw-type endosseous dental implant with a soft tissue level design and internal connection, which allows for compatibility with various prosthetic components like abutments and impression copings.

  • How is the Allfit Implant System supplied and what components is it compatible with?

    The device is supplied as part of the Allfit Implant System and is compatible with components such as impression copings, implant analogs, abutments, straight multi-unit abutments, scan bodies, titanium bases, locators, locator R-TX, ball attachments, screws, and screwdrivers, enabling a full prosthetic workflow from implant placement to final restoration.