InstaGums® Soft Tissue Material

GUDID 00841549118524

1x50ml cart.15 mix&15 oral tips

STERNGOLD DENTAL LLC

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: 00841549118524
• NIH Device Record Key: 81850962-9e20-468a-9bf8-8f1c79f8071a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstaGums® Soft Tissue Material
• Version Model Number: 222025
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549118524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992609

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2023-07-26
• Device Publish Date: 2023-07-18

Devices Manufactured by STERNGOLD DENTAL LLC

• 00841549119163 - MOR: 2024-04-22 Comfort Cap 10 pack
• 00841549119170 - MOR: 2024-04-22 Comfort Cap 4 pack
• 00841549118289 - Platinum Foil 1 DWT: 2023-10-16 92mm x 32mm x .02 mm thick
• 00841549108280 - MOR®-A Implant: 2023-10-13 3.0 x 10mm, Ti
• 00841549108297 - MOR®-A Implant: 2023-10-13 3.0 x 13mm, Ti
• 00841549108303 - MOR®-A Implant: 2023-10-13 3.0 x 15mm, Ti
• 00841549108310 - MOR®-A Implant: 2023-10-13 3.0 x 18mm, Ti
• 00841549115707 - TRU®/PUR® Surgical Kit: 2023-10-13