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FDA 510(k)

Advanced Dental Appliance

K-Number: K203462 · 2021-02-19

ApplicantDasoft Partners
Decision Date2021-02-19
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Advanced Dental Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Dasoft Partners. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K203462. 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 Advanced Dental Appliance?

Advanced Dental Appliance is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Dasoft Partners. The 510(k) number is K203462.

When did Advanced Dental Appliance receive FDA 510(k) clearance?

Advanced Dental Appliance received FDA 510(k) clearance on 2021-02-19, under 510(k) number K203462.

Who is the listed applicant for Advanced Dental Appliance?

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

What is the FDA product code for Advanced Dental Appliance?

The FDA product code for Advanced Dental Appliance is LRK.

Other records listing Dasoft Partners 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.

K172991Advanced Dental Applicance

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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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