Concinnity Aligners

GUDID 00850028222003

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).

DRAKE PRECISION DENTAL LABORATORY, INC.

Orthodontic progressive aligner

• Primary Device ID: 00850028222003
• NIH Device Record Key: 2616de12-33de-4be0-bc81-b97ca14f1c92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Concinnity Aligners
• Version Model Number: CA0000000001
• Company DUNS: 024484784
• Company Name: DRAKE PRECISION DENTAL LABORATORY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com
• Phone: 7048452401
• Email: bsavage@drakelab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850028222003 [Primary]

FDA Product Code

• NXC: Aligner, Sequential

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-02
• Device Publish Date: 2022-01-25