SciPharm Anterior/Posterior Composite Bonding Agent, Part A 50-043

GUDID D801SP500431

Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I and Class II Restoratives., Part A

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin

• Primary Device ID: D801SP500431
• NIH Device Record Key: 7fb45e17-a213-42cc-a9b9-67f4059b0adf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Anterior/Posterior Composite Bonding Agent, Part A
• Version Model Number: SP 50-043
• Catalog Number: 50-043
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP500431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791078

FDA Product Code

• EBD: Coating, Filling Material, 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: 2016-07-07

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