SciPharm Anterior/Posterior Resin Based Paste/Paste Spanish 50-04

GUDID D801SP5004S1

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

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin

• Primary Device ID: D801SP5004S1
• NIH Device Record Key: cb0583a7-b870-4cc4-9805-a96c90676d6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Anterior/Posterior Resin Based Paste/Paste Spanish
• Version Model Number: SP 50-04 S
• Catalog Number: 50-04
• 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	D801SP5004S1 [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

Devices Manufactured by SCIENTIFIC PHARMACEUTICALS, INC.

• D801SP70211 - DFV Desensitizing Varnish (Wonderful Varnish) Bubblegum (Tutti-Fruity): 2022-01-27 DFV Desensitizing Varnish (Wonderful Varnish), Bubblegum (Tutti-Fruity) flavor, is a fluoride-containing resin preparation for t
• D801SP70221 - DFV Desensitizing Varnish (Wonderful Varnish) Spearmint: 2022-01-27 DFV Desensitizing Varnish (Wonderful Varnish), Spearmint flavor, is a fluoride-containing resin preparation for the treatment of
• D801SP70231 - DFV Desensitizing Varnish (Wonderful Varnish) Chocolate: 2022-01-27 DFV Desensitizing Varnish (Wonderful Varnish), Chocolate flavor, is a fluoride-containing resin preparation for the treatment of
• D801SP70241 - DFV Desensitizing Varnish (Wonderful Varnish) Marshmallow: 2022-01-27 DFV Desensitizing Varnish (Wonderful Varnish), Marshmallow flavor, is a fluoride-containing resin preparation for the treatment
• D801SP70201 - DFV Desensitizing Varnish (Wonderful Varnish) Strawberry: 2021-08-16 DFV Desensitizing Varnish (Wonderful Varnish), Strawberry flavor, is a fluoride-containing resin preparation for the treatment
• D801AV44001 - Improv Temporary Implant Cement by Dentegris Dental Implant System: 2020-12-21 Improv - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants and Conventional Crown and Bridge
• D801IMPROVECEMENT1 - Improv Temporary Implant Cement by Salvin Dental Specialties: 2020-12-21 Improv - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants and Conventional Crown and Bridge
• D80150041 - SciPharm Anterior/Posterior Composite Resin Paste/Paste: 2018-07-06 Anterior/Posterior Resin Based Restorative Material