BASIS

Basic Information

• Brand Name: BASIS
• Primary DI: 00889989080391
• Version / Model: 776-2103
• Company Name: ORMCO CORPORATION
• Labeler DUNS: 154614119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2021-10-11
• Public Version Status: Update
• Public Device Record Key: 69e3fa2f-7b7f-4787-9250-664e31b63d7e

Device Description

Dust Free Dental Alginate Impression Material

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
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	00889989080391	GS1
Unit of Use	10889989075578	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160441	000

Device Sizes

Type	Value	Unit	Text
Weight	2.72	Kilogram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store below 85