D-Lish Varnish Sample

GUDID 10302732956158

Varnish sample for US and Canada

YOUNG DENTAL MANUFACTURING I, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: 10302732956158
• NIH Device Record Key: e8317be7-dd01-408d-9a5e-5afb040c0c82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-Lish Varnish Sample
• Version Model Number: 295615
• Company DUNS: 006309355
• Company Name: YOUNG DENTAL MANUFACTURING I, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10302732956158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080814

FDA Product Code

• LBH: Varnish, Cavity

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-09-27
• Device Publish Date: 2016-10-26

On-Brand Devices [D-Lish Varnish Sample]

• 10302739996348: Varnish sample for US only
• 10302732956158: Varnish sample for US and Canada