LITE ART 1976

GUDID E23519760

LITE ART KAHAKI

SHOFU DENTAL CORPORATION

Dental unfilled resin sealant/coating

• Primary Device ID: E23519760
• NIH Device Record Key: 4225ca14-4591-455b-aeea-4b7843282676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LITE ART
• Version Model Number: 1976
• Catalog Number: 1976
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• 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: 760-566-3528
• Email: ckaemmerlen@shofu.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23519760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101621

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [LITE ART]

• E23519860: LITE ART LIQUID
• E23519850: LITE ART YELLOW
• E23519840: LITE ART MAGENTA
• E23519830: LITE ART CYAN
• E23519820: LITE ART BLACK BROWN
• E23519810: LITE ART DARK RED BROWN
• E23519800: LITE ART ORANGE BROWN
• E23519790: LITE ART VIOLET
• E23519780: LITE ART BLUE GREY
• E23519770: LITE ART ORANGE
• E23519760: LITE ART KAHAKI
• E23519750: LITE ART B SHADE
• E23519740: LITE ART A SHADE
• E23519730: LITE ART RED
• E23519720: LITE ART BLACK
• E23519710: LITE ART WHITE
• E23519700: LITE ART FULL SET