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Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars

by Implant Innovations, Inc.

510(k) K052648

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

13 closed

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 · Special NumberK052648 Date20 Oct 2005ClearedStatusActive

Recalls

13 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0078-2021 FDA Class II initiated 31 Aug 2020
    • Terminated Z-0079-2021 FDA Class II initiated 31 Aug 2020
    • Terminated Z-0075-2021 FDA Class II initiated 31 Aug 2020
    • Terminated Z-0074-2021 FDA Class II initiated 31 Aug 2020
    • Terminated Z-0077-2021 FDA Class II initiated 31 Aug 2020
    • Terminated Z-0076-2021 FDA Class II initiated 31 Aug 2020
    • Terminated Z-0073-2021 FDA Class II initiated 31 Aug 2020

    Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient

  • 5 recalls, same reason

    • Terminated Z-2143-2019 FDA Class II initiated 26 Feb 2019
    • Terminated Z-2140-2019 FDA Class II initiated 26 Feb 2019
    • Terminated Z-2141-2019 FDA Class II initiated 26 Feb 2019
    • Terminated Z-2142-2019 FDA Class II initiated 26 Feb 2019
    • Terminated Z-2144-2019 FDA Class II initiated 26 Feb 2019

    During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.

    • Terminated Z-1215-2014 FDA Class II initiated 26 Aug 2013

    Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.

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  • Withdrawn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
NHA
Device Class
Class II
Regulation
21 CFR Part 872.3630
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.

This device is a modification to 3i patient-specific dental abutments and overdenture bars, intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It supports single and multiple tooth prostheses in the mandible or maxilla, with prostheses that can be screw or cement retained to the abutment.

The device is supplied as a modification to existing patient-specific dental abutments and overdenture bars. It is regulated under FDA 510(k) clearance (K052648) with product code NHA, classified as a Class II endosseous dental implant accessory under 21 CFR 872.3640. The device is intended for use in dental clinical settings by qualified professionals.

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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 intended use of this device?

    This device is intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient, supporting single and multiple tooth prostheses in the mandible or maxilla with screw or cement retention.

  • How is this device supplied?

    The device is supplied as a modification to existing patient-specific dental abutments and overdenture bars, meaning it is not a standalone product but an alteration to previously manufactured patient-specific components.

  • What regulatory pathway was used for this device?

    The device is regulated under FDA 510(k) clearance (K052648) with product code NHA, classified as a Class II endosseous dental implant accessory under 21 CFR 872.3640, and was found substantially equivalent to a predicate device.