Orthocryl®

Basic Information

• Brand Name: Orthocryl®
• Primary DI: J011160403000
• Version / Model: 160-403-00
• 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: 7
• Public Version Date: 2022-10-21
• Public Version Status: Update
• Public Device Record Key: 78dc79d9-4a45-4d31-beb8-c50fef1f589d
• Distribution End Date: 2021-06-02

Device Description

Orthocryl® LC, red/ orthodontic acrylics

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
KMY	POSITIONER, TOOTH, PREFORMED	Dental	872.5525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65677	Orthodontic palate expander screw, bonded	An orthodontic device intended to be used as part of a bonded palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to affect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J011160403000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K942667	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Close cartridges after use / Store in a cool environment (not above 25 °C/ 77°F) and protect from contamination and sunlight as they may cause premature polymerization.