SciPharm Until Temporary Crown and Bridge Cement 55-25

GUDID D801SP5525S1

Until - An Advanced Eugenol Free Solution for Temporary Crown and Bridge Cementation. Spanish

SCIENTIFIC PHARMACEUTICALS, INC.

Glass ionomer dental cement

• Primary Device ID: D801SP5525S1
• NIH Device Record Key: f9a27dba-c4b3-430d-8aa3-48e1a8ed911e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Until Temporary Crown and Bridge Cement
• Version Model Number: SP 55-25 S
• Catalog Number: 55-25
• 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 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	D801SP5525S1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884081

FDA Product Code

• EMA: Cement, Dental

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: 2016-08-08

On-Brand Devices [SciPharm Until Temporary Crown and Bridge Cement]

• D801SP55261: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Resin Adhe
• D801SP5525S1: Until - An Advanced Eugenol Free Solution for Temporary Crown and Bridge Cementation. Spanish
• D801SP55256N1: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Resin Adhe
• D801SP55256B1: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Resin Adhe
• D801SP55254N1: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Releasing
• D801SP55254B1: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Releasing
• D801SP55253N1: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Dentin Sea
• D801SP55253B1: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Dentin Sea
• D801SP55252N1: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Part B. N
• D801SP55252B1: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Part B. B
• D801SP55251N1: Until - An Advanced Eugenol Free Solution for Temporary Crown and Bridge Cementation. Part A.
• D801SP55251B1: Until - An Advanced Eugenol Free Solution for Temporary Crown and Bridge Cementation. Part A.
• D801SP55251: Until - An Advanced Eugenol Free Solution for Temporary Crown and Bridge Cementation
• D80155261N1: Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Resin Adhe