AccessGUDID - DEVICE: Unison® Spherical Alloy (D00265726121)

GUDID

Device Identifier (DI) Information

Brand Name: Unison® Spherical Alloy
Version or Model: 657-2612
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 657-2612
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00265726121
Issuing Agency: HIBCC
Commercial Distribution End Date: June 05, 2024
Device Count: 50
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Unison® Spherical Alloy Self-Activating Capsules, 2 Spill, 500 (600mg) Orange/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: 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 in a well-ventilated place and do not exceed 25 segrees Celsius.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 Jars of 50 Orange/White Capsules per box (600mg alloy each capsule) No.2 Spill

Device Record Status

Public Device Record Key: 62de75a5-7ab2-4d71-9443-ffd6fe24e89c
Public Version Date: June 06, 2024
Public Version Number: 3
DI Record Publish Date: September 21, 2016