N.A.

Basic Information

• Brand Name: N.A.
• Primary DI: J0111631100000
• Version / Model: 163-110-00
• Company Name: DENTAURUM GmbH & Co.KG
• Labeler DUNS: 315427286
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-02
• Public Version: 1
• Public Version Date: 2019-04-10
• Public Version Status: New
• Public Device Record Key: 85178471-333c-442a-bc79-eba2064aaaf7

Device Description

"CONTEC lc assortment / adhesive / Light-curing / For bonding metal brackets and buccal tubes, ceramic brackets and plastic brackets. "

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	J0111631100000	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 4-28°C/39-82°F/Protect from strong light or intense heat. Light sensitive. If room temp. exceeds 28°C/82 °F, store in refrigerator. Do not deep-freeze.