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Bluephase Style 20i

by Ivoclar Vivadent AG

510(k) K163613

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 NumberK163613 Date4 Apr 2017ClearedStatusActive

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  • Withdrawn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
EBZ
FDA applicant
Ivoclar Vivadent, AG
Device class
Class II
Regulation
21 CFR Part 872.6070
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 Bluephase Style 20i is an ultraviolet activator for polymerisation, classified as a dental curing light. It employs LED technology to cure dental restorative materials, ensuring precise and efficient hardening of composites, resins, and other photopolymerisable substances used in restorative dentistry.

This device is designed for use in dental clinics and offices, supplied as a reusable, non-sterile instrument. It operates in four modes, including a corded backup power supply, and features a broadband LED spectrum for unrestricted clinical application. The Bluephase Style 20i has received FDA 510(k) clearance under the Abbreviated pathway, with a classification of Class II (device code EBZ). It is manufactured in Austria and distributed by Ivoclar Vivadent.

From the manufacturer

The Bluephase 20i is high-performance LED curing light with a light intensity of 2,000 mW/cm2 offering curing times as fast as 5 seconds.

Source: ivoclar.com

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