Ormco Spark Aligner System

FDA 510(k) K182826 · Sybron Dental Specialties

Substantially Equivalent

510(k) numberK182826

Submission

Device name
Ormco Spark Aligner System
Applicant
Sybron Dental Specialties
Orange, CA, US
Received
October 5, 2018
Decision date
October 11, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
NXC – Aligner, Sequential
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

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Questions and answers

When was Ormco Spark Aligner System cleared by the FDA?

Ormco Spark Aligner System (K182826) received a 510(k) decision of Substantially Equivalent on October 11, 2018, 6 days after the submission was received.

What is the product code of K182826?

The FDA product code is NXC – Aligner, Sequential, a Class II (moderate risk) device regulated under 21 CFR 872.5470.