IMPRESSION TRAY LRG

GUDID 00850007728397

IMPRESSION TRAY LARGE SIZE

Access Dental Lab, LLC

Dental impression tray, single-use

• Primary Device ID: 00850007728397
• NIH Device Record Key: e9917809-f2fe-4b9b-8263-8bfa5d9c3a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPRESSION TRAY LRG
• Version Model Number: 200-0014
• Company DUNS: 054012763
• Company Name: Access Dental Lab, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007728397 [Primary]

FDA Product Code

• EBH: Material, Impression Tray, Resin

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: 2023-02-27
• Device Publish Date: 2023-02-17

Devices Manufactured by Access Dental Lab, LLC

• 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: 2023-02-27IMPRESSION TRAY LARGE SIZE
• 00850007728397 - IMPRESSION TRAY LRG: 2023-02-27 IMPRESSION TRAY LARGE SIZE