SciPharm Cemper Permanent Dental Cement 51-251

GUDID D801SP51251B1

Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physical properties are optimized for better working time, ease of placement, and longevity in the oral environment. Part A, Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin Dental composite resin

• Primary Device ID: D801SP51251B1
• NIH Device Record Key: de884c87-79e4-4ecb-9650-6491d768956e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Cemper Permanent Dental Cement
• Version Model Number: SP 51-251 B
• Catalog Number: 51-251
• 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 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP51251B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904024

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: 2016-08-04

On-Brand Devices [SciPharm Cemper Permanent Dental Cement]

• D801SP5125S1: Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physic
• D801SP51253N1: Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physic
• D801SP51253B1: Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physic
• D801SP51252N1: Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physic
• D801SP51252B1: Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physic
• D801SP51251N1: Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physic
• D801SP51251B1: Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physic
• D801SP51251: Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physic