Skip to content

New Outline

by Anaxdent GmbH

510(k) K023079

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 NumberK023079 Date30 Oct 2002ClearedStatusActive

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  • Withdrawn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
EBG
Device Class
Class II
Regulation
21 CFR Part 872.3770
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

New Outline is a PMMA resin material designed for the creation of temporary dental restorations. It is suitable for a variety of applications including single crowns, implant-supported restorations, mock-ups, occlusal tables, and denture repairs.

This system is available in various colors and can be processed via conventional casting, injection, or CAD/CAM milling. The material is designed to be trimmed and polished, and it has received FDA 510K authorization under K023079.

Other devices from Anaxdent GmbH

Questions

AI-generated answers, 24 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 clinical applications is New Outline suitable for?

    New Outline is a PMMA resin designed for the fabrication of various temporary dental restorations. This includes single crowns, implant-supported restorations, mock-ups, occlusal tables, and the repair of dentures.

  • How can the New Outline material be processed?

    This material is versatile and supports multiple processing methods to suit different laboratory workflows. It can be processed using conventional casting, injection techniques, or modern CAD/CAM milling systems.

  • What is the regulatory status of the New Outline system?

    New Outline has received FDA 510K authorization under K023079. The device was determined to be substantially equivalent to existing products within the dental advisory committee category.

  • Is the material ready for use immediately after processing?

    After the initial processing via casting, injection, or milling, the material is designed to be trimmed and polished to achieve the final desired shape and surface finish for the temporary restoration.