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TelioCAD Multi

by Ivoclar Vivadent, Inc.

510(k) K153753

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 NumberK153753 Date12 Apr 2016ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

TelioCAD Multi is a dental CAD/CAM block used for the manufacture of long-term temporaries with a maximum wear period of 12 months. The restorations can be milled in the dental practice, in a dental laboratory, or outsourced to a milling center.

The device is supplied as resin blocks for crown and bridge applications and is classified under product code EBG with Class II special controls. It is authorized under FDA 510(k) clearance K153753, issued on April 12, 2016.

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Questions

AI-generated answers, 25 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 TelioCAD Multi used for?

    TelioCAD Multi is a dental CAD/CAM block specifically designed for the manufacture of long-term temporaries with a maximum wear period of 12 months, suitable for crown and bridge applications.

  • How is TelioCAD Multi supplied?

    The device is supplied as resin blocks that can be milled in the dental practice, in a dental laboratory, or outsourced to a milling center for creating restorations.

  • What is the regulatory status of TelioCAD Multi?

    TelioCAD Multi is authorized under FDA 510(k) clearance K153753, issued on April 12, 2016, and is classified under product code EBG with Class II special controls.

  • Can TelioCAD Multi be reused after milling?

    The device information does not specify whether TelioCAD Multi blocks can be reused after milling, as it is designed for manufacturing single restorations from each block.