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Bluephase PowerCure 100-240V

by Ivoclar Vivadent AG 3 variants

Ref 667092BE

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190272↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07615208458763 UDI-DI Date19 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number76152081XLAMP001YD Basic UDI-DI 07615208458763UDI-DIDate25 Nov 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK190272 Date3 Jul 2019IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Bluephase PowerCure 100-240V EUDAMED
Bluephase PowerCure GUDID
Generic Name
Dental/surgical polymerization lamp
Device Name
Bluephase EasyCure, Bluephase G4 100, Bluephase G4, Bluephase N G4, Bluephase N-Cure, Bluephase PowerCure
Model / Ref / Catalog
667092BE
Primary DI / UDI-DI
07615208458763
Basic UDI-DI
76152081XLAMP001YD
Direct Marketing DI
07615208461275
FDA Product Code
EBZ
EMDN Code
Z12119003 Cold light dental equipment
GMDN Term
Dental/surgical polymerization lamp
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.6070
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
LI-MF-000000522

Other devices from Ivoclar Vivadent AG

See all devices from Ivoclar Vivadent AG →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No