SDC-impression material (Kulzer)

GUDID 00850007728250

putty material used to create dental impressions.

Access Dental Lab, LLC

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• Primary Device ID: 00850007728250
• NIH Device Record Key: cd91c836-f62f-4144-ad57-6709067fe25e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SDC-impression material (Kulzer)
• Version Model Number: 200-0107
• Company DUNS: 054012763
• Company Name: Access Dental Lab, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850007728250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000629

FDA Product Code

• ELW: Material, Impression

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): 2023-02-27putty 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