Bluephase EasyCure 762137BU

GUDID 07615208478181

Bluephase EasyCure 100-240V

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental/surgical polymerization lamp
Primary Device ID07615208478181
NIH Device Record Keyba106989-16e2-4cdc-96b6-07364574e9c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBluephase EasyCure
Version Model Number762137BU
Catalog Number762137BU
Company DUNS448015938
Company NameIVOCLAR VIVADENT AKTIENGESELLSCHAFT
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107615208476217 [Primary]
GS107615208478181 [Direct Marking]

FDA Product Code

EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


[07615208478181]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-03
Device Publish Date2024-09-25

Devices Manufactured by IVOCLAR VIVADENT AKTIENGESELLSCHAFT

07615208488401 - OptraSculpt2026-01-23 OptraSculpt Refill/ Pointed Tip/ 60
07615208445596 - OptraSculpt2026-01-23 OptraSculpt Refill/ Chisel/ 60
07615208445602 - OptraSculpt2026-01-23 OptraSculpt Refill/ Ball/ 60
07615208486254 - OptraSculpt2026-01-23 OptraSculpt Pad Refill/6 mm/60
07615208445947 - OptraSculpt2026-01-23 OptraSculpt Pad Refill/4 mm/60
07615208590296 - Tetric CAD2026-01-21 Tetric CAD for PrograMill MT BL C14/5
07615208590258 - Tetric CAD2026-01-21 Tetric CAD for PrograMill MT A3.5 C14/5
07615208590265 - Tetric CAD2026-01-21 Tetric CAD for PrograMill MT A3 C14/5

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.