MOR®-A Implant

GUDID 00841549108303

3.0 x 15mm, Ti

STERNGOLD DENTAL LLC

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• Primary Device ID: 00841549108303
• NIH Device Record Key: 1029923a-15c0-4401-afcd-10b2ad92d592
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOR®-A Implant
• Version Model Number: 901496
• 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: true
• 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
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549108303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171728

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-13
• Device Publish Date: 2023-10-05

On-Brand Devices [MOR®-A Implant]

• 00841549108310: 3.0 x 18mm, Ti
• 00841549108303: 3.0 x 15mm, Ti
• 00841549108297: 3.0 x 13mm, Ti
• 00841549108280: 3.0 x 10mm, Ti