Dentis SQ-SL AXEL Fixture
K-Number: K253493 · 2026-03-04
ApplicantDentis Co., Ltd.
Decision Date2026-03-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dentis SQ-SL AXEL Fixture is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2026-03-04 under approval number K253493. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dentis SQ-SL AXEL Fixture?
Dentis SQ-SL AXEL Fixture is a medical device that received FDA 510(k) clearance on 2026-03-04. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K253493.
When was Dentis SQ-SL AXEL Fixture approved by the FDA?
Dentis SQ-SL AXEL Fixture received FDA 510(k) clearance on 2026-03-04, under approval number K253493.
What company makes Dentis SQ-SL AXEL Fixture?
Dentis SQ-SL AXEL Fixture is manufactured by Dentis Co., Ltd..
What is the FDA product code for Dentis SQ-SL AXEL Fixture?
The FDA product code for Dentis SQ-SL AXEL Fixture is DZE.
Other Devices by Dentis Co., Ltd.
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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.