AccessGUDID - DEVICE: Genie MagicMix® Ultra Hydrophilic Impression Standard (D6870078830FG1)

GUDID

Device Identifier (DI) Information

Brand Name: Genie MagicMix® Ultra Hydrophilic Impression Standard
Version or Model: 0078830FG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0078830FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6870078830FG1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Genie MagicMix® Heavy Body Rapid Set Bulk

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
ELW	MATERIAL, IMPRESSION

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
Storage Environment Temperature: between 5 and 27 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Total Volume: 380 Milliliter
Device Size Text, specify: Genie MagicMix® Heavy Body Rapid Set (4) 380 mL cartridges and 1 Bayonet Ring

Device Record Status

Public Device Record Key: d6449c67-554e-4bc3-bee3-7a83878826d2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016