SCOTT'S SELECT ALLOY 500/jar 2 SPILL

Basic Information

• Brand Name: SCOTT'S SELECT ALLOY 500/jar 2 SPILL
• Primary DI: D77810615130
• Version / Model: 106-1513
• Catalog Number: 106-1513
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2017-05-25
• Public Version: 4
• Public Version Date: 2020-08-26
• Public Version Status: Update
• Public Device Record Key: 165a55f7-7d3c-4acd-bf94-735edcee9be7

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJJ	Alloy, Amalgam	Dental	872.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D77810615130	HIBCC
Unit of Use	D77810615131	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140125	000

Device Sizes

Type	Value	Unit	Text
Weight	600	Milligram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool well-ventilated place