SmileDirectClub Retainer

GUDID 00850007728427

SmileDirectClub Retainers consist of a clear plastic removable orthodontic appliance which are intended to hold the teeth in their current position.

Access Dental Lab, LLC

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• Primary Device ID: 00850007728427
• NIH Device Record Key: 2c298366-a89b-4a28-8dcc-b0aacbea7e80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmileDirectClub Retainer
• Version Model Number: 140-0004
• Company DUNS: 054012763
• Company Name: Access Dental Lab, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com
• Phone: 901-361-0576
• Email: joe.miller@accessdentallab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007728427 [Primary]

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: 2023-12-08
• Device Publish Date: 2023-11-30

Devices Manufactured by Access Dental Lab, LLC

• 00850007728427 - SmileDirectClub Retainer: 2023-12-08SmileDirectClub Retainers consist of a clear plastic removable orthodontic appliance which are intended to hold the teeth in their current position.
• 00850007728427 - SmileDirectClub Retainer: 2023-12-08 SmileDirectClub Retainers consist of a clear plastic removable orthodontic appliance which are intended to hold the teeth in the
• 00850007728243 - SDC impression material (Zest): 2023-02-27 impression material used to create dental impressions
• 00850007728250 - SDC-impression material (Kulzer): 2023-02-27 putty material used to create dental impressions.
• 00850007728342 - Smile stretcher-purple bag: 2023-02-27 Smile stretcher in foil purple pouch
• 00850007728366 - Impression Tray XSM: 2023-02-27 Impression Tray Extra Small
• 00850007728373 - IMPRESSION TRAY SM: 2023-02-27 IMPRESSION TRAY SMALL SIZE
• 00850007728380 - IMPRESSION TRAY MED: 2023-02-27 IMPRESSION TRAY MEDIUM SIZE
• 00850007728397 - IMPRESSION TRAY LRG: 2023-02-27 IMPRESSION TRAY LARGE SIZE