DigiGuide System

FDA 510(k) K193499 · Protomed, Inc.

Substantially Equivalent

510(k) numberK193499

Submission

Device name
DigiGuide System
Applicant
Protomed, Inc.
Westminster, CO, US
Received
December 17, 2019
Decision date
November 4, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DZJ – Driver, Wire, And Bone Drill, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Specialty
Dental

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Questions and answers

When was DigiGuide System cleared by the FDA?

DigiGuide System (K193499) received a 510(k) decision of Substantially Equivalent on November 4, 2020, 323 days after the submission was received.

What is the product code of K193499?

The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.