FDA 510(k)

Dental LT Comfort Resin

K-Number: K232087 · 2024-02-16

Decision Date2024-02-16

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

Dental LT Comfort 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 2024-02-16 under 510(k) number K232087. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental LT Comfort Resin?

Dental LT Comfort Resin is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Formlabs Ohio, Inc.. The 510(k) number is K232087.

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

Dental LT Comfort Resin received FDA 510(k) clearance on 2024-02-16, under 510(k) number K232087.

Who is the listed applicant for Dental LT Comfort 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 Comfort Resin?

The FDA product code for Dental LT Comfort Resin is MQC.

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.

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Official Source

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