Saliva-Check

Basic Information

• Brand Name: Saliva-Check
• Primary DI: D0470045041
• Version / Model: 004504
• Catalog Number: 004504
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-01-24
• Public Version: 3
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: ae5f51f6-a582-458f-9681-ebbe7f6982af
• Distribution End Date: 2018-02-16

Device Description

Saliva-Check Mutans Kit, (10) test kits wich include: 1 Mutans Test Device, 1 paraffin Gum, 1 Pipette, 1 Mixing Container, 1 bottle of Reagent #1 (2mL) and 1 bottle of Reagent #2 (4mL)

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
EGD	WAX, DENTAL, INTRAORAL	Dental	872.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61719	Saliva pH IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of salivary pH within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. Saliva pH is an indicator of oral health and a prolonged acidic environment is associated with erosion of tooth enamel, dental caries, or eventually periodontal disease. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0470045041	HIBCC
Unit of Use	D0470045040	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.