Calibra® Esthetic Resin Cement

Basic Information

• Brand Name: Calibra® Esthetic Resin Cement
• Primary DI: D0026070721
• Version / Model: 607072
• Catalog Number: 607072
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: f535a044-3a74-47cb-bcce-d283145654b3

Device Description

Calibra® Esthetic Resin Cement, Try-In Paste, Medium, 2 (1.8g) syringe Refill Package

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: Yes
• 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
61482	Dental cement trial	A non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. 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	D0026070721	HIBCC
Unit of Use	D0026070720	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040906	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2 Syringes Calibra® Try-In Paste (1.8g each)
Weight	1.8	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight. Keep dry.
• Type: Storage Environment Temperature
• Temperature Range: 10 – 24 Degrees Celsius