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Ips E. Max Press Abutment Solutions for Nobel Biocare

by Ivoclar Vivadent, Agin

510(k) K124008

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 · Abbreviated NumberK124008 Date29 Mar 2013ClearedStatusActive

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  • Withdrawn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
NHA
Device Class
Class II
Regulation
21 CFR Part 872.3630
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

IPS e.max Press abutment solutions are dental devices designed for use in restorative dentistry. They are intended for the fabrication of hybrid abutment solutions involving single-tooth restorations in the anterior and posterior regions.

These abutment solutions are supplied as part of a premarket notification filed with the FDA under K124008. The device received a substantially equivalent determination and is classified as FDA Class 2 under regulation number 872.3630 for dental specialty use.

Questions

AI-generated answers, 22 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 IPS e.max Press abutment solution used for?

    The IPS e.max Press abutment solution is designed for use in restorative dentistry to fabricate hybrid abutment solutions for single-tooth restorations in both anterior and posterior regions of the mouth.

  • How is the IPS e.max Press abutment solution supplied?

    The device is supplied as part of a premarket notification filed with the FDA under K124008, indicating it was submitted for regulatory review as a medical device for dental specialty use.

  • Is the IPS e.max Press abutment solution a single-use or reusable device?

    The device data does not specify whether the IPS e.max Press abutment solution is intended for single-use or reuse; therefore, no determination about reusability can be made from the provided information.

  • What regulatory pathway was used for the IPS e.max Press abutment solution?

    The device received a substantially equivalent determination through the FDA's 510(k) premarket notification process, as indicated by the authorization type FDA_510K and decision code SESE.

  • What is the classification of the IPS e.max Press abutment solution?

    The device is classified as FDA Class 2 under regulation number 872.3630 for dental specialty use, based on its substantially equivalent determination.