PRG Barrier Coat Y2910

GUDID E235Y29100

PRG BARRIER COAT SET BOTTLE TYPE

SHOFU DENTAL CORPORATION

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• Primary Device ID: E235Y29100
• NIH Device Record Key: eb264f47-6b17-433c-8407-60f7fb85be58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRG Barrier Coat
• Version Model Number: Y2910
• Catalog Number: Y2910
• 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: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235Y29100 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-13
• Device Publish Date: 2024-03-05

On-Brand Devices [PRG Barrier Coat]

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