AccessGUDID - DEVICE: Heliosit (DVIV532629AN1)

GUDID

Device Identifier (DI) Information

Brand Name: Heliosit
Version or Model: 532629AN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 532629AN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DVIV532629AN1
Issuing Agency: HIBCC
Commercial Distribution End Date: April 03, 2024
Device Count: 3
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: Heliosit Orthodontic Refill 3x2,5 g

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:	Yes
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?
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

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: 2245e7c3-e2f7-49dd-bc76-9d71b96d4077
Public Version Date: April 04, 2024
Public Version Number: 4
DI Record Publish Date: December 12, 2016