TherTray1 3/4/-Arch UL-LR

Basic Information

• Brand Name: TherTray1 3/4/-Arch UL-LR
• Primary DI: 00859787002086
• Version / Model: 116
• Company Name: ADVANTAGE DENTAL PRODUCTS INC
• Labeler DUNS: 607859147
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2016-11-04
• Public Version: 3
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: 9d7f2ba7-f1bc-432f-aacb-e3a91540dcad
• Distribution End Date: 2021-10-31

Device Description

Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression materials.

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: No
• 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
EHY	Tray, Impression, Preformed	Dental	872.6880	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16350	Dental impression tray, single-use	A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10859787002083	GS1	Box	10	Not in Commercial Distribution	2021-10-31
Primary	00859787002086	GS1
Unit of Use	00859787002208	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
• Type: Storage Environment Temperature
• Temperature Range: – 125 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: – 125 Degrees Fahrenheit