Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sapphire Dorsal Comfort Fit

K-Number: K181416 · 2019-09-17

ApplicantCrane Dental Laboratory, Inc.
Decision Date2019-09-17
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sapphire Dorsal Comfort Fit is the device name listed in this FDA 510(k) record. The listed applicant is Crane Dental Laboratory, Inc.. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K181416. 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 Sapphire Dorsal Comfort Fit?

Sapphire Dorsal Comfort Fit is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is Crane Dental Laboratory, Inc.. The 510(k) number is K181416.

When did Sapphire Dorsal Comfort Fit receive FDA 510(k) clearance?

Sapphire Dorsal Comfort Fit received FDA 510(k) clearance on 2019-09-17, under 510(k) number K181416.

Who is the listed applicant for Sapphire Dorsal Comfort Fit?

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

What is the FDA product code for Sapphire Dorsal Comfort Fit?

The FDA product code for Sapphire Dorsal Comfort Fit is LRK.

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.

↑