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FDA 510(k)

THERASOM-CAST

K-Number: K113516 · 2013-01-04

ApplicantFamily Dental Services, P.C.
Decision Date2013-01-04
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THERASOM-CAST is the device name listed in this FDA 510(k) record. The listed applicant is Family Dental Services, P.C.. It received FDA 510(k) clearance on 2013-01-04 under 510(k) number K113516. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERASOM-CAST?

THERASOM-CAST is a medical device that received FDA 510(k) clearance on 2013-01-04. The listed applicant is Family Dental Services, P.C.. The 510(k) number is K113516.

When did THERASOM-CAST receive FDA 510(k) clearance?

THERASOM-CAST received FDA 510(k) clearance on 2013-01-04, under 510(k) number K113516.

Who is the listed applicant for THERASOM-CAST?

The FDA 510(k) record lists Family Dental Services, P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERASOM-CAST?

The FDA product code for THERASOM-CAST is LRK.

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Related Devices (Code: LRK)

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

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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