STANDBY ALGINATE ALTERNATIVE 50ml CART 4/pk

Basic Information

• Brand Name: STANDBY ALGINATE ALTERNATIVE 50ml CART 4/pk
• Primary DI: D77810463011
• Version / Model: 104-6301
• Catalog Number: 104-6301
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-10-25
• Public Version: 3
• Public Version Date: 2020-08-26
• Public Version Status: Update
• Public Device Record Key: eb00ad13-6a8d-4acb-8cb7-212947f606a4

Device Description

Alginate Alternative is an addition cured elastomeric vinyl impression material specifically formulated to be used as an alternative to traditional alginate materials. Intended to be used primarily for taking impressions for case study models, temporary crown and bridge fabrication, partial denture impression, Orthodontic models and counter impressions .Alginate Alternative is a non-toxic material that, when set, is chemically resistant. For SDS and instructions for use visit https://www.scottsdental.com/impression-material/alginate-substitutes/standby-alginate-alternative.html

Device Characteristics

• Single Use: No
• 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
ELW	Material, Impression	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D77810463011	HIBCC
Unit of Use	D77810463010	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 72 Degrees Fahrenheit