SciPharm Cemper Permanent Dental Cement 51-253

GUDID D801SP51253N1

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. Dentin Sealer Bottle. Non-Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin Dental composite resin

• Primary Device ID: D801SP51253N1
• NIH Device Record Key: 185ad62a-5e9c-4d99-ae24-56d79432a8f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Cemper Permanent Dental Cement
• Version Model Number: SP 51-253 N
• Catalog Number: 51-253
• 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 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP51253N1 [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: 2016-08-03

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