International Dental Supply Luster Polishing Paste 50-05

GUDID D801ID5005I1

IDS Dental Polishing Paste for Composite Restoratives, Amalgams, and Castings. Italian

SCIENTIFIC PHARMACEUTICALS, INC.

Dentifrice

• Primary Device ID: D801ID5005I1
• NIH Device Record Key: 43bede8a-db0e-4a36-835f-269ce6da2478
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: International Dental Supply Luster Polishing Paste
• Version Model Number: ID 50-05
• Catalog Number: 50-05
• Company DUNS: 096010525
• Company Name: SCIENTIFIC PHARMACEUTICALS, INC.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-634-3047
• Email: Denise@scipharm.com
• Phone: 800-634-3047
• Email: Denise@scipharm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801ID5005I1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K842403

FDA Product Code

• EJR: Agent, Polishing, Abrasive, Oral 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-11

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