D-Lish Vanilla Cupcake Varnish 50

GUDID 20302732144507

YOUNG DENTAL MANUFACTURING I, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: 20302732144507
• NIH Device Record Key: 34249102-5374-4a19-a62d-4eefb79b0c86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-Lish Vanilla Cupcake Varnish 50
• Version Model Number: 214450
• 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	10302732144500 [Primary]
GS1	20302732144507 [Package]; Contains: 10302732144500; Package: shipping box [56 Units]; In Commercial Distribution

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: 2016-09-16

Devices Manufactured by YOUNG DENTAL MANUFACTURING I, LLC

• 10816577024588 - Young Dental, Infinity: 2024-10-08 Barrier Sleeve, Young Infinity Cordless Handpiece, 500ct
• 00816577024598 - Young Dental, Infinity: 2024-10-08 Sleeve for Infinity, 25ct (Purchase Only When Ordered by W&H)
• 10816577024601 - Denticator: 2024-10-08 Denticator Universal Air Water Syringe Sleeve, Infection Control Barrier
• 10816577024618 - Denticator: 2024-10-08 Denticator High Speed Short Pen Sleeve, Infection Control Barrier
• 10816577024625 - Denticator: 2024-10-08 Denticator Light Handle Sleeve, Infection Control Barrier
• 10816577024632 - Denticator: 2024-10-08 Denticator Low Speed Handpiece Sleeve, Infection Control Barrier
• 10302730003243 - Young Dental: 2024-10-07 Cup, Purple, Web, Petite, Soft, LF, Latch, 144ct SAMPLE
• 10302730003250 - Young Dental: 2024-10-07 Cup, Young Brands, Purple, Web, Long, Soft, LF, Latch, 144ct SAMPLE