Sildent Bite

Basic Information

• Brand Name: Sildent Bite
• Primary DI: 18809746990076
• Version / Model: Bite Registration Material
• Company Name: HRS Co., Ltd.
• Labeler DUNS: 688000574
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 1
• Public Version Date: 2020-12-17
• Public Version Status: New
• Public Device Record Key: cbfa5b52-9961-44f0-844d-efee53817f88

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Unit of Use	08809746990079	GS1
Primary	18809746990076	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181604	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 12 – 25 Degrees Celsius