3D Dental - Dream

GUDID 00817169020189

DREAM FLUORIDE VARNISH SPEARMINT .40 ML BOX/50

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: 00817169020189
• NIH Device Record Key: 0294a918-c169-4541-95d9-9d856104aa13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Dental - Dream
• Version Model Number: DFVSM
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817169020189 [Primary]
GS1	10817169020186 [Package]; Package: Case/12 [600 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-12-12

On-Brand Devices [3D Dental - Dream]

• 00817169020189: DREAM FLUORIDE VARNISH SPEARMINT .40 ML BOX/50
• 00817169020172: DREAM FLUORIDE VARNISH BUBBLE GUM .40 ML BOX/50
• 00817169021483: DREAM FLUORIDE VARNISH MELON..40 ML BOX/50