Young Dental

GUDID 00302730003307

ClearDefense Silver Fluoride Hypersensitivity Varnish

YOUNG DENTAL MANUFACTURING I, LLC

Dental coating, tooth-desensitizing, professional

• Primary Device ID: 00302730003307
• NIH Device Record Key: b84b2c52-b52c-42dc-84f6-9231f4588924
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Young Dental
• Version Model Number: 296906
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: (800) 325-1881
• Email: customerservice@younginnovations.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00302730003307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241041

FDA Product Code

• PHR: Diammine Silver Fluoride Dental Hypersensitivity Varnish

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: 2025-03-17
• Device Publish Date: 2025-03-07

On-Brand Devices [Young Dental]

• 00840326405949: DISCLOSING TABLETS-DUOTONE mfg#243225
• 00302730003291: CUP PETITE WEB LF PPL 144CT SAMPLE
• 00302730003284: CUP ELITE FLEX LF PINK 144CT SAMPLE
• 10302730003274: WEB LF SFT PPL SCR 144 SAMPLE
• 10302730003267: Cup, Young Brands, Elite, X-Soft, LF, Latch Type, 144ct SAMPLE
• 10302730003250: Cup, Young Brands, Purple, Web, Long, Soft, LF, Latch, 144ct SAMPLE
• 10302730003243: Cup, Purple, Web, Petite, Soft, LF, Latch, 144ct SAMPLE
• 10302732957186: Disclosing Tablets, Zooby Dual Detection, 250ct
• 10302732342258: 2 TONE DISCL TABLET 250 COUNT
• 10302732342104: 2 TONE TABLETS 1000 PK
• 20302732342002: 2-TONE DISC TAB BULK
• 00302732331026: 2 TONE DISCLOSING SOL 2 OZ
• 10302732330040: 2 TONE SOLUTION 4 GALLON
• 10302732322250: TRACE DISCL TABLET 250 COUNT
• 10302732322106: TRACE TABLETS 1000 PK
• 20302732322004: TRACE-28 DISC TAB BULK PK
• 20302732311022: TRACE DISCLOSING SOL. 2OZ.
• 00302730003307: ClearDefense Silver Fluoride Hypersensitivity Varnish
• 00302730003383: ClearDefense Silver Fluoride Hypersensitivity Varnish