N.A.

Basic Information

• Brand Name: N.A.
• Primary DI: J011163307000
• Version / Model: 163-307-00
• Company Name: DENTAURUM GmbH & Co.KG
• Labeler DUNS: 315427286
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2022-05-02
• Public Version Status: Update
• Public Device Record Key: a0ccf6f4-6df5-4313-9847-cc8621f1f95a
• Distribution End Date: 2022-04-30

Device Description

ConTec Go! Ready-to-use one component bracket adhesive in syringes / For further information please visit our online-shop on our website www.dentaurum.de

Device Characteristics

• Single Use: Yes
• 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
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. 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	J011163307000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K030644	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at 5 - 25 °c / 41 - 77 °F / Remove package from refrigerator at least 30 minutes before use to guarantee that material reaches room temperature (15 - 25 °C / 41 - 77 °F).