Primeprint Ortho

Basic Information

• Brand Name: Primeprint Ortho
• Primary DI: EDET027851
• Version / Model: 02785
• Company Name: DETAX GmbH
• Labeler DUNS: 343947949
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-12
• Public Version: 3
• Public Version Date: 2022-11-08
• Public Version Status: Update
• Public Device Record Key: cc780dea-87ab-44bb-ad88-a2747944d075

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
EBH	Material, Impression Tray, Resin	Dental	872.3670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63997	Orthodontic appliance positioning tray	A custom-made dental device in the form of a patient’s dentition with slots/sockets intended to position and hold in place a set of orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) [not included] to bond them to teeth during a single procedure; the orthodontic appliances are loaded onto the device by the orthodontist prior to the procedure. Also known as an indirect bonding tray, it is typically made of synthetic polymer materials and is manufactured from an oral cavity impression or oral scan for a specific patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EDET027851	HIBCC