Question 1

Who is the manufacturer of GATES GLIDDEN DRILLS?

Accepted Answer

The Hygenic Corp. filed the 510(k) submission for GATES GLIDDEN DRILLS (K905418).

Question 2

What is the FDA product code for GATES GLIDDEN DRILLS?

Accepted Answer

DZA. It is classified under 21 CFR 872.4130 as a Class 1 device in the Dental panel.

Question 3

When was GATES GLIDDEN DRILLS cleared by the FDA?

Accepted Answer

Jul 25, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for GATES GLIDDEN DRILLS?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like GATES GLIDDEN DRILLS?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K905418
Device Name	GATES GLIDDEN DRILLS
Applicant	The Hygenic Corp.
Product Code	DZA · Dental
Decision Date	Jul 25, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4130
Device Class	Class 1

GATES GLIDDEN DRILLS

Device Facts

Regulatory Classification

Identification