Bite Blocks

Basic Information

• Brand Name: Bite Blocks
• Primary DI: 00190746074288
• Version / Model: 855-200
• Catalog Number: 855-200
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Labeler DUNS: 044668515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-24
• Public Version: 3
• Public Version Date: 2022-04-11
• Public Version Status: Update
• Public Device Record Key: afb9585f-d7ce-4b9f-946c-445fcedea641

Device Description

DB LINGUAL BITE BLOCK SHORT 10/PKG

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: 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
DYT	MAINTAINER, SPACE PREFORMED, ORTHODONTIC	Dental	872.5525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62683	Tongue-training dental orthosis	A non-sterile intraoral device intended to be fixed/cemented to the teeth long-term (> 30 days) to stimulate the tongue to reposition itself during swallowing, speech, and resting posture to retrain the tongue such as to reduce the pressure on the teeth. Often referred to as a lingual spur it includes a sharp/pointed stem(s) intended to discourage undesirable tongue positioning, and is often used in conjunction with preventing/reducing overbite. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190746074288	GS1

Customer Contacts

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