Concinnity Aligners

Basic Information

• Brand Name: Concinnity Aligners
• Primary DI: 00850028222003
• Version / Model: CA0000000001
• Company Name: DRAKE PRECISION DENTAL LABORATORY, INC.
• Labeler DUNS: 024484784
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-25
• Public Version: 1
• Public Version Date: 2022-02-02
• Public Version Status: New
• Public Device Record Key: 2616de12-33de-4be0-bc81-b97ca14f1c92

Device Description

The Concinnity Aligners™ are a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as an alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment. Intended Use / Indications for Use: The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXC	Aligner, Sequential	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44738	Orthodontic progressive aligner	A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850028222003	GS1

Customer Contacts

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