N.A.

Basic Information

• Brand Name: N.A.
• Primary DI: J0111631190000
• Version / Model: 163-119-00
• Company Name: DENTAURUM GmbH & Co.KG
• Labeler DUNS: 315427286
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 2
• Public Version Date: 2022-01-24
• Public Version Status: Update
• Public Device Record Key: 376f59fb-aa6f-4109-912d-970eb195edc3
• Distribution End Date: 2022-01-22

Device Description

CONTEC disposable tube / adhesive / For etching gel (REF 163-115-00).

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: No
• 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	J0111631190000	HIBCC
Unit of Use	J0111631190001	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: No special storage conditions required