Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D9439013BOSTS0
• Version / Model: 9013-BOSTS
• Catalog Number: 9013-BOSTS
• Company Name: Power Dental U.S.A. Inc.
• Labeler DUNS: 081305064
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-13
• Public Version: 4
• Public Version Date: 2023-06-23
• Public Version Status: Update
• Public Device Record Key: 91894621-41e8-44cd-a577-0eaac301e165

Device Description

OSTEOTOME LONG SET (8 PCS) (With 13mm handle)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GFI	OSTEOTOME, MANUAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15713	Dental rongeur	A strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.	No	Active
44886	Dental osteotome set	A collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D9439013BOSTS0	HIBCC

Customer Contacts

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