Ceramic Lingual Button

Basic Information

• Brand Name: Ceramic Lingual Button
• Primary DI: 10190886010433
• Version / Model: CLB10
• 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: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: aec9aad1-9655-45d7-8282-130be3757319

Device Description

The Freddy™ ceramic button is the perfect clear utility button for all aesthetic appliances. •Works lingually as well as labially •The Oral surgeons use them whenever clear appliances are indicated •Mesh structure of base makes a strong bonding •Bonds well with most common adhesives •Anatomy and size of base fits all teeth •Enough space around tie wing for all elastics •Maintains the transparent look with aligners as anchorage for elastics

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
NJM	Bracket, Ceramic, Orthodontic	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58937	Orthodontic bracket, ceramic	A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. 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	10190886010433	GS1
Unit of Use	07333117000087	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132368	000