Pi-Ku-Plast HP 36 polymer 54000215

GUDID EBRE540002159

Pi-Ku-Plast HP 36 polymer 85 g

bredent GmbH & Co. KG

Dental composite resin

• Primary Device ID: EBRE540002159
• NIH Device Record Key: d76144b3-246e-4cb0-83d5-f885b8fe58d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pi-Ku-Plast HP 36 polymer
• Version Model Number: 54000215
• Catalog Number: 54000215
• Company DUNS: 341086190
• Company Name: bredent GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• 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: false

Customer Support Contacts

• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBRE540002150 [Primary]
HIBCC	EBRE540002159 [Package]; Contains: EBRE540002150; Package: dummy [1 Units]; Discontinued: 2023-11-23; Not in Commercial Distribution

FDA Product Code

• EGD: WAX, DENTAL, INTRAORAL

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: 2023-12-01
• Device Publish Date: 2023-11-23

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