AccessGUDID - DEVICE: Dispersalloy® Dispersed Phase Alloy (D0026562631)

GUDID

Device Identifier (DI) Information

Brand Name: Dispersalloy® Dispersed Phase Alloy
Version or Model: 656263
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 656263
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026562631
Issuing Agency: HIBCC
Commercial Distribution End Date: February 28, 2023
Device Count: 500
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Dispersed Phase Alloy, Fast Set, 3 Spill, 2000 (800mg) Yellow/White caps

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: Yes 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: Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Fast Set, 3 Spill, 4 cartons of 500 (800mg) Yellow/White caps
Weight: 800 Milligram

Device Record Status

Public Device Record Key: b584c713-e2e5-4ae4-a61e-ac1a6aac1f1f
Public Version Date: March 27, 2023
Public Version Number: 3
DI Record Publish Date: September 21, 2016