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Proximerge 2 Dental Implant System

by Quadric Biomed, LLC

510(k) K211409

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 NumberK211409 Date19 Oct 2022ClearedStatusActive

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  • Withdrawn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, 23 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 Proximerge 2 Dental Implant System is a dental implant device used for replacing missing teeth. It consists of implants that are surgically placed into the jawbone to support dental prostheses.

The system is supplied as a single-use device and is not MRI safe. It is authorized under FDA 510K clearance with product code DZE. The device should be stored according to the manufacturer's instructions.

Other devices from Quadric Biomed, LLC

Questions

AI-generated answers, 23 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 Proximerge 2 Dental Implant System used for?

    The Proximerge 2 Dental Implant System is designed to replace missing teeth by surgically placing implants into the jawbone to support dental prostheses. It provides a foundation for artificial teeth that look, feel, and function like natural teeth.

  • Is the Proximerge 2 Dental Implant System reusable or single-use?

    The Proximerge 2 Dental Implant System is supplied as a single-use device. It should not be reused on multiple patients as this could compromise sterility and device performance. Each implant is intended for one-time use only.

  • What are the storage requirements for the Proximerge 2 Dental Implant System?

    The Proximerge 2 Dental Implant System should be stored according to the manufacturer's instructions. Proper storage conditions are essential to maintain the integrity and sterility of the device until it is ready for surgical use.

  • Is the Proximerge 2 Dental Implant System MRI safe?

    No, the Proximerge 2 Dental Implant System is not MRI safe. Patients with these implants should avoid MRI scans unless specifically cleared by their healthcare provider, as the device may interfere with the imaging process or cause potential complications.