ORL-E-92 Surgical Drill System

Q: What is the product code of K984244?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.

FDA 510(k) K984244 · Bien Air USA, Inc.

Substantially Equivalent

510(k) numberK984244

Submission

Device name: ORL-E-92 Surgical Drill System
Applicant: Bien Air USA, Inc.
San Diego, CA, US
Received: November 27, 1998
Decision date: February 23, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: EFB – Handpiece, Air-Powered, Dental
Device class: Class I (low risk)
Regulation: 21 CFR 872.4200
Specialty: Dental

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More from Ttbio Corp.

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K983183	Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch…EFB · Traditional	12/10/1998SE

Questions and answers

When was ORL-E-92 Surgical Drill System cleared by the FDA?

ORL-E-92 Surgical Drill System (K984244) received a 510(k) decision of Substantially Equivalent on February 23, 1999, 88 days after the submission was received.

What is the product code of K984244?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.