EXPERIENCE

Basic Information

• Brand Name: EXPERIENCE
• Primary DI: D78812192C3479221
• Version / Model: 12/19-2C34-7922
• Catalog Number: 12/19-2C34-7922
• Company Name: Gc Orthodontics America Inc.
• Labeler DUNS: 063167128
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2021-08-27
• Public Version: 1
• Public Version Date: 2021-09-06
• Public Version Status: New
• Public Device Record Key: 19c1a1a6-28de-475d-aea7-9b6f5d1d5d58

Device Description

EXCM/EXMRC MBT 022 U/L 5-5 HK U3 L 34

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: No
• 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
EJF	BRACKET, METAL, ORTHODONTIC	Dental	872.5410	1
NJM	Bracket, ceramic, orthodontic	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46581	Orthodontic bracket, metal	A metallic device that is bonded to an orthodontic band, or directly 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
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
Unit of Use	D78812192C3479220	HIBCC
Primary	D78812192C3479221	HIBCC

Customer Contacts

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