Stern Vantage® Varnish LC

GUDID 00841549118203

5.0ml bottle

STERNGOLD DENTAL LLC

Dental cavity varnish

• Primary Device ID: 00841549118203
• NIH Device Record Key: c68bb8c5-4026-4bc3-a1b9-c0fcd310d680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stern Vantage® Varnish LC
• Version Model Number: 220232
• 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	00841549118203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984341

FDA Product Code

• EGG: Attachment, Precision, All

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

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• 00841549119194 - Stern Snap One Piece Abutment 2mm Cuff (BK): 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
• 00841549119200 - Stern Snap One Piece Abutment 3mm Cuff (BK): 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
• 00841549119217 - Stern Snap One Piece Abutment 4mm Cuff (BK): 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
• 00841549119224 - Stern Snap One Piece Abutment 5mm Cuff (BK): 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
• 00841549119231 - Stern Snap Abutment Base 2.4mm (BK): 2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
• 00841549119248 - Stern Snap Abutment Base 3.0mm (BK): 2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
• 00841549119255 - Stern Snap Abutment Base 4.0mm (BK): 2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota