AccessGUDID - DEVICE: Megalloy®EZ Spherical Amalgam (D0026030041)

GUDID

Device Identifier (DI) Information

Brand Name: Megalloy®EZ Spherical Amalgam
Version or Model: 603004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 603004
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026030041
Issuing Agency: HIBCC
Commercial Distribution End Date: February 10, 2023
Device Count: 50
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 1 Spill (Red)

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?
34836	Dental amalgam alloy	A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJJ	Alloy, amalgam

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
Special Storage Condition, Specify: Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 400 Milligram
Device Size Text, specify: No. 1 Spill (Red): 10 jars of 50 Capsules (400mg alloy each capsule)

Device Record Status

Public Device Record Key: a2577eb7-7571-4b08-ab3b-797824edd815
Public Version Date: March 27, 2023
Public Version Number: 3
DI Record Publish Date: September 21, 2016