BISICO Cementime DC

Basic Information

• Brand Name: BISICO Cementime DC
• Primary DI: EBIB037301
• Version / Model: 03730
• Catalog Number: 03730
• Company Name: bisico Bielefelder Dentalsilicone GmbH & Co. KG
• Labeler DUNS: 316133664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-29
• Public Version: 4
• Public Version Date: 2020-06-29
• Public Version Status: Update
• Public Device Record Key: 18e7a981-a865-4f6a-9fcd-ab43dd747335

Device Description

Dual-curing, semipermanent luting cement for crowns and bridges on dental implants

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMA	Cement, Dental	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16703	Ethoxy benzoic acid dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between ethoxy benzoic acid (EBA) and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EBIB037301	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K091735	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 20 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: – 20 Degrees Celsius