Ca-Lok - Calcium Base / Liner 05-7500

GUDID D8370575000

Ca-Lok™ is a light-cured, calcium-filled resin with adhesive properties to dentin and seamless compatibility to other restorative materials. Ca-Lok™ is radiopaque and releases fluoride. Ca-Lok™ is used as a protective liner with adhesion, which can be placed under restorative materials and cements for many types of cavity preparations. With its flowable viscosity and unique handling characteristics, precise placement and control is achieved.

Taub Products

Dental composite resin

• Primary Device ID: D8370575000
• NIH Device Record Key: 5a574194-3877-4486-82ad-a05115725fcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ca-Lok - Calcium Base / Liner
• Version Model Number: 0.9 gm Syr Evaluator
• Catalog Number: 05-7500
• Company DUNS: 067488114
• Company Name: Taub Products
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1.201.798.5353
• Email: customerservice@taubdental.com
• Phone: +1.201.798.5353
• Email: customerservice@taubdental.com

Device Dimensions

• Weight: 0.9 Gram
• Weight: 0.9 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat. Store at room temperature. See SDS.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat. Store at room temperature. See SDS.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8370575000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153191

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: 2016-10-26

On-Brand Devices [Ca-Lok - Calcium Base / Liner]

• D8370575000: Ca-Lok™ is a light-cured, calcium-filled resin with adhesive properties to dentin and seamless
• D8370570000: Ca-Lok™ is a light-cured, calcium-filled resin with adhesive properties to dentin and seamless