OrthoStore - REPLICA, NO FLAVOR ALGINATE

Basic Information

• Brand Name: OrthoStore - REPLICA, NO FLAVOR ALGINATE
• Primary DI: 00843471100103
• Version / Model: 625-963
• Catalog Number: 625-963
• Company Name: YOUNG INNOVATIONS HOLDINGS LLC
• Labeler DUNS: 078739060
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-23
• Public Version: 4
• Public Version Date: 2022-09-27
• Public Version Status: Update
• Public Device Record Key: 500c22d9-9c1d-40f6-9b57-a112ec315d3a

Device Description

REPLICA, NO FLAVOR ALGINATE

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: Yes
• Has Expiration Date: No
• 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
35863	Alginate dental impression material	A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is 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	00843471100103	GS1

Premarket Submissions

Submission Number	Supplement Number
K925746	000