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FDA 510(k)

Dental LT Clear V2 Resin

K-Number: K222061 · 2022-11-10

ApplicantFormlabs Ohio, Inc.
Decision Date2022-11-10
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Dental LT Clear V2 Resin is the device name listed in this FDA 510(k) record. The listed applicant is Formlabs Ohio, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K222061. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental LT Clear V2 Resin?

Dental LT Clear V2 Resin is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Formlabs Ohio, Inc.. The 510(k) number is K222061.

When did Dental LT Clear V2 Resin receive FDA 510(k) clearance?

Dental LT Clear V2 Resin received FDA 510(k) clearance on 2022-11-10, under 510(k) number K222061.

Who is the listed applicant for Dental LT Clear V2 Resin?

The FDA 510(k) record lists Formlabs Ohio, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental LT Clear V2 Resin?

The FDA product code for Dental LT Clear V2 Resin is MQC.

Related Clinical Trials

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.

NCT07350343The Predictability of Directly Printed Versus Thermoformed Clear AlignersENROLLING_BY_INVITATIONNCT07551024Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic MaxillaRECRUITINGNCT07687329Direct vs Indirect In-House Clear Aligners vs Fixed Appliances in Orthodontic TreatmentCOMPLETED

Other records listing Formlabs Ohio, Inc. 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.

K262300Denture Base Resin V2K240538Premium Teeth ResinK232087Dental LT Comfort Resin

Related Devices (Code: MQC)

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.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material CorporationK241729Hard Splint & Thermo-Adaptive SplintWhip Mix CorporationK243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

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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