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 a medical device manufactured by Crane Dental Laboratory, Inc.. It received FDA 510(k) clearance on 2019-09-17 under approval 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. It is manufactured by Crane Dental Laboratory, Inc.. The 510(k) number is K181416.
When was Sapphire Dorsal Comfort Fit approved by the FDA?
Sapphire Dorsal Comfort Fit received FDA 510(k) clearance on 2019-09-17, under approval number K181416.
What company makes Sapphire Dorsal Comfort Fit?
Sapphire Dorsal Comfort Fit is manufactured by Crane Dental Laboratory, Inc..
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)
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.