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FDA 510(k)

Dental Pain Eraser

K-Number: K182947 · 2019-03-26

Decision Date2019-03-26
Product CodeLWM
DecisionSubstantially Equivalent

Device Summary

Dental Pain Eraser is the device name listed in this FDA 510(k) record. The listed applicant is Synapse Dental, LLC. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K182947. The device is classified under product code LWM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Pain Eraser?

Dental Pain Eraser is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Synapse Dental, LLC. The 510(k) number is K182947.

When did Dental Pain Eraser receive FDA 510(k) clearance?

Dental Pain Eraser received FDA 510(k) clearance on 2019-03-26, under 510(k) number K182947.

Who is the listed applicant for Dental Pain Eraser?

The FDA 510(k) record lists Synapse Dental, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Pain Eraser?

The FDA product code for Dental Pain Eraser is LWM.

Other records listing Synapse Dental, LLC 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.

Related Devices (Code: LWM)

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.

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.