PowerScrew 12

Basic Information

• Brand Name: PowerScrew 12
• Primary DI: 09120074342118
• Version / Model: 10965
• Company Name: Tiger Dental GmbH
• Labeler DUNS: 300597738
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-06
• Public Version: 1
• Public Version Date: 2026-02-16
• Public Version Status: New
• Public Device Record Key: af9fe39c-ef09-463f-8ebb-0b5c04d2aaa5

Device Description

Bone Anchorage-Growth Appliances are orthodontic treatment devices intended for correction of malocclusion and promoting bone growth.

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	872.5410	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	09120074342118	GS1

Customer Contacts

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