AccessGUDID - DEVICE: Bluephase PowerCure (DIVO6670931)

GUDID

Device Identifier (DI) Information

Brand Name: Bluephase PowerCure
Version or Model: 667093
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 667093
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO6670931
Issuing Agency: HIBCC
Commercial Distribution End Date: May 25, 2022
Device Count: 3
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: Bluephase PowerCure handpiece, Bluephase PowerCure battery, Bluephase PowerCure light guide

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35775	Dental/surgical polymerization lamp	A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBZ	ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ae4b0ac8-8a55-4da9-9a3e-343c512c6669
Public Version Date: May 26, 2022
Public Version Number: 3
DI Record Publish Date: November 05, 2019