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Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM, Model 29315

by Nobel Biocare USA, LLC

510(k) K052885

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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) K052885↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK052885 Date23 Dec 2005ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
NHA
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 872.3630
Advisory Committee
Dental
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 Zygoma 17 Abutment Multi-Unit RP is classified as an Abutment, Implant, Dental, serving as a prosthetic interface for zygoma implants. It functions as a mechanical connector between the implant and dental prosthesis, facilitating prosthetic rehabilitation in patients requiring multi-unit restorations. Constructed from surgical-grade titanium, these abutments ensure durability and biocompatibility, enabling precise seating for dental prostheses.

These abutments are designed for use in clinical dental settings by trained professionals, providing a stable connection for multi-unit dental restorations. Supplied sterile and intended for single-use, they are available in two reference codes: Model 29314 (2mm) and Model 29315 (3mm). The devices comply with FDA 510(k) clearance and MDR regulations, with a classification under product code NHA. No MRI safety information or reusable specifications are provided.

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Questions

AI-generated answers, 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.

  • What is the primary purpose of the Zygoma 17 Abutment Multi-Unit RP in dental prosthetics?

    The Zygoma 17 Abutment Multi-Unit RP serves as a mechanical connector between zygoma implants and dental prostheses, enabling stable and precise seating for multi-unit restorations. It acts as the prosthetic interface to support complex dental reconstructions in patients requiring extensive rehabilitation.

  • Are these abutments reusable, or are they intended for single-use only?

    These abutments are explicitly intended for single-use only, as stated in the manufacturer’s specifications. They are supplied sterile to ensure clinical safety and reliability during use.

  • What materials are the Zygoma 17 Abutment Multi-Unit RP abutments made from, and why does this matter?

    The abutments are constructed from surgical-grade titanium, which provides both durability and biocompatibility. This material choice ensures long-term stability within the patient’s oral environment and minimizes the risk of adverse reactions.

  • What size options are available for the Zygoma 17 Abutment Multi-Unit RP, and how do they differ?

    Two reference models are available: Model 29314 (2mm) and Model 29315 (3mm). The difference lies in the abutment’s height, which may be selected based on the specific anatomical requirements of the patient’s zygoma implant site and the desired prosthetic fit.

  • How should these abutments be stored before use, and what regulatory compliance do they meet?

    Since they are supplied sterile, these abutments should be stored in their original packaging until ready for use to maintain sterility. They comply with both FDA 510(k) clearance (K052885) and MDR regulations, ensuring adherence to stringent safety and performance standards.