Bite-Bumper

Basic Information

• Brand Name: Bite-Bumper
• Primary DI: 10190886000748
• Version / Model: BB-00-01
• Catalog Number: BB-00-01
• Company Name: G & H Wire Company, Inc.
• Labeler DUNS: 831465641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 4
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: b6c1b0eb-7f01-402e-9c31-6d6ce5d5a3ff

Device Description

Bite Bumpers™ work to open deep bite cases by allowing the anteriors to ride up and out of occlusion. The Bite Bumpers™ eliminate bond failures of brackets and are especially valuable with ceramic or self-ligating brackets. The unique fixed "placement-jig" guarantees the correct height on the lingual of the tooth an makes sure the two Bite Bumpers™ are 100% parallel. The Bite Bumpers™ are made of a composite polymer that is more comfortable, aesthetic and will increase biocompatibility in nickel sensitive patients. Bite-Bumpers™ are bonded in the same manner as plastic or composite brackets with a slotted mechanical bonding base. Bite Bumper is a registered trademark by Gestenco International AB, Sweden

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: 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
DYW	Bracket, Plastic, Orthodontic	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46582	Orthodontic bracket, plastic, single-use	A plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. 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	10190886000748	GS1
Unit of Use	07333117000070	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053055	000