Bluephase PowerCure 667093

GUDID DIVO6670931

Bluephase PowerCure handpiece, Bluephase PowerCure battery, Bluephase PowerCure light guide

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp

• Primary Device ID: DIVO6670931
• NIH Device Record Key: ae4b0ac8-8a55-4da9-9a3e-343c512c6669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bluephase PowerCure
• Version Model Number: 667093
• Catalog Number: 667093
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DIVO6670930 [Unit of Use]
HIBCC	DIVO6670931 [Primary]

FDA Product Code

• EBZ: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-26
• Device Publish Date: 2019-11-05

On-Brand Devices [Bluephase PowerCure]

• DIVO6670931: Bluephase PowerCure handpiece, Bluephase PowerCure battery, Bluephase PowerCure light guide
• DIVO7409981: Bluephase G4 handpiece, Bluephase G4 battery, Bluephase G4 light guide
• DVIV691918BU1: Blueph. PowerCure & System Kit mixed
• DVIV668253BU1: Bluephase PowerCure & System Kit syringe
• 07615208461299: Bluephase PowerCure 100-240V
• 07615208461251: Bluephase PowerCure 100-240V