PRG Barrier Coat 1786

GUDID E23517860

PRG BARRIER COAT MINI KIT

SHOFU DENTAL CORPORATION

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• Primary Device ID: E23517860
• NIH Device Record Key: 96181c61-5de3-4b6c-99d5-5b8d4b38db27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRG Barrier Coat
• Version Model Number: 1786
• Catalog Number: 1786
• 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
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23517860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122908

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: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-23

On-Brand Devices [PRG Barrier Coat]

• E23517950: PRG BARRIER COAT
• E23517860: PRG BARRIER COAT MINI KIT
• E235Y29100: PRG BARRIER COAT SET BOTTLE TYPE