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Bioceram Dental Implant, Series II

by Kyocera America, Inc.

510(k) K904450

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 NumberK904450 Date9 Jul 1991ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

Bioceram Dental Implant, Series II is a dental implant device. It is substantially equivalent to a legally marketed device and has received FDA 510(k) clearance under product code DZE.

The device is supplied by Kyocera America, Inc. and is intended for use in dental applications. It is a reusable or single-use device as determined by its labeling, with no MRI safety information provided in the data. Storage and handling should follow manufacturer instructions.

Questions

AI-generated answers, 25 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 Bioceram Dental Implant, Series II used for?

    The Bioceram Dental Implant, Series II is intended for use in dental applications as a dental implant device, based on its labeling and intended use as described in the device data.

  • Is the Bioceram Dental Implant, Series II reusable or single-use?

    The device is described as reusable or single-use as determined by its labeling, meaning the specific use designation depends on the instructions provided by Kyocera America, Inc. for this particular model.

  • How is the Bioceram Dental Implant, Series II supplied and by whom?

    The Bioceram Dental Implant, Series II is supplied by Kyocera America, Inc., located at 8611 Balboa Ave., San Diego, CA 92123, as indicated in the manufacturer and address details provided.

  • What regulatory pathway was used for the Bioceram Dental Implant, Series II?

    The device received FDA 510(k) clearance through a traditional review process, as indicated by the clearance_type and decision_code fields showing it is substantially equivalent to a legally marketed device.

  • Does the Bioceram Dental Implant, Series II include MRI safety information?

    No MRI safety information is provided in the device data for the Bioceram Dental Implant, Series II, so users should consult the labeling or manufacturer for specific safety details regarding magnetic resonance imaging environments.