Oscillating Microsaw

Basic Information

• Brand Name: Oscillating Microsaw
• Primary DI: J00716012980011
• Version / Model: 1601298-001
• Company Name: Bien-Air Dental SA
• Labeler DUNS: 480082080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-07
• Public Version: 1
• Public Version Date: 2026-04-15
• Public Version Status: New
• Public Device Record Key: 8ec97cae-aec3-4c3f-93c5-60774072d656

Device Description

The OSCILLATING MICROSAW is adapted for procedures requiring high precision in confined or curved spaces, such as jaw realignment or craniofacial reconstruction. The controlled motion minimizes the risk of damaging nearby tissues.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• 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
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J00716012980011	HIBCC

Customer Contacts

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