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Hollow Basket Dental Implants

by Artech Corp.

510(k) K843217

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 NumberK843217 Date15 Oct 1984ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 27 Sep 2026

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

Hollow basket dental implants are root-form endosseous dental implants characterized by a basket geometry. This device type is one of four geometrically distinct types of root-form endosseous dental implants, which also include screw, solid cylinder, and hollow cylinder designs.

The device received FDA 510(k) clearance (K843217) on October 15, 1984, and was found substantially equivalent to a predicate device. It is classified under product code DZE and was reviewed by the Dental advisory committee (DE).

Other devices from Artech Corp.

See all devices from Artech Corp. →

Questions

AI-generated answers, 27 Sep 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 intended use of hollow basket dental implants?

    Hollow basket dental implants are root-form endosseous dental implants designed for surgical placement in the jawbone to support prosthetic teeth, utilizing a basket geometry for bone integration.

  • How are hollow basket dental implants supplied and sterilized?

    The device data does not specify supply format, sterility, or single-use/reuse status; these details must be obtained from the manufacturer's labeling or instructions for use.

  • What sizes or models are available for hollow basket dental implants?

    The provided data does not include specific sizes, models, or reference numbers beyond the device name and K843217; dimensional or variant information is not available in this record.

  • What regulatory pathway was used for hollow basket dental implants?

    The device received FDA 510(k) clearance under K843217 on October 15, 1984, following a traditional review process and was found substantially equivalent to a predicate device.

  • Who manufactures hollow basket dental implants and where are they located?

    Hollow basket dental implants are manufactured by Artech Corp., located at 2901 Telestar Ct., Falls Church, VA 22042, United States, as indicated in the device registration details.