AccessGUDID - DEVICE: Megalloy®EZ Spherical Amalgam (D0026030151)

GUDID

Device Identifier (DI) Information

Brand Name: Megalloy®EZ Spherical Amalgam
Version or Model: 603015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 603015
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026030151
Issuing Agency: HIBCC
Commercial Distribution End Date: August 01, 2021
Device Count: 250
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 2 Spill Case (Purple)

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
Device Size Text, specify: No. 2 Spill Case (Purple) 4 Jars of 250 Capsules (600mg alloy each Capsule)
Weight: 600 Milligram

Device Record Status

Public Device Record Key: 2f2b609f-6b70-4d8b-808c-506b7208e1eb
Public Version Date: December 13, 2023
Public Version Number: 3
DI Record Publish Date: September 21, 2016