3M™ Unitek™ APC™ Clarity™ MBT™

Basic Information

• Brand Name: 3M™ Unitek™ APC™ Clarity™ MBT™
• Primary DI: 00652221236890
• Version / Model: 4003-304
• Catalog Number: 4003-304
• Company Name: 3M UNITEK CORPORATION
• Labeler DUNS: 008256356
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 2
• Public Version Date: 2019-02-12
• Public Version Status: Update
• Public Device Record Key: 8e280ba5-ec70-4ff3-9ff7-84f8828da6a6

Device Description

APC FF Clarity Ultra SL MBT U Rt Lateral 10T/8A 022

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: 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
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN	Dental	872.3750	2
NJM	Bracket, ceramic, orthodontic	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	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
Primary	00652221236890	GS1
Unit of Use	80652221236896	GS1

Customer Contacts

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