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FDA 510(k)

Inspire ICE aka Inspire ICE Clear Brackets

K-Number: K171844 · 2017-07-18

ApplicantOrmco Corporation
Decision Date2017-07-18
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Inspire ICE aka Inspire ICE Clear Brackets is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corporation. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K171844. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Inspire ICE aka Inspire ICE Clear Brackets?

Inspire ICE aka Inspire ICE Clear Brackets is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Ormco Corporation. The 510(k) number is K171844.

When did Inspire ICE aka Inspire ICE Clear Brackets receive FDA 510(k) clearance?

Inspire ICE aka Inspire ICE Clear Brackets received FDA 510(k) clearance on 2017-07-18, under 510(k) number K171844.

Who is the listed applicant for Inspire ICE aka Inspire ICE Clear Brackets?

The FDA 510(k) record lists Ormco Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inspire ICE aka Inspire ICE Clear Brackets?

The FDA product code for Inspire ICE aka Inspire ICE Clear Brackets is NJM.

Other records listing Ormco Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250487SparkTM Clear Aligner SystemK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveK240501Spark™ Clear Aligner SystemK203737Spark Clear Aligner SystemK172845Symetri Clear

Related Devices (Code: NJM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232827LightForce Orthodontic SystemLightforce OrthodonticsK232011CleoAmerican OrthodonticsK231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna FlexK222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos MedicosK222764LightForce Orthodontic SystemLightforce Orthodontics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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