Devices

K3 Engine File GPack

Model / Serial
Lot Number: 08E182E.
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- US, including the territory of St. Thomas, and countries of Australia, Canada, New Zealand, China, Singapore, India, and Chile.
Product Description
K3 Engine File G-Pack, || Product: Endodontic Pulp Canal File, Part Number: 830-9925. || For use in root canal preparation.
Manufacturer
Ormco Corporation
1 Event
- Recall of K3 Engine File GPack

Manufacturer

Ormco Corporation

Manufacturer Address
Ormco Corporation, 1332 S Lone Hill Ave, Glendora CA 91740
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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