Burkhart 10:1 Temp C&B Material A1 76g

GUDID 00854212006615

BURKHART DENTAL SUPPLY CO., THE

Silicone dental impression material

• Primary Device ID: 00854212006615
• NIH Device Record Key: c48079d0-4cc8-4ee5-b7dd-0b11814f8373
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burkhart 10:1 Temp C&B Material A1 76g
• Version Model Number: 72720594
• Company DUNS: 027532357
• Company Name: BURKHART DENTAL SUPPLY CO., THE
• 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: true
• 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: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com
• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854212006615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102753

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2016-09-16

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