SIMPLANT 18
K-Number: K172239 · 2018-04-04
ApplicantDentsply Sirona
Decision Date2018-04-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIMPLANT 18 is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2018-04-04 under approval number K172239. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SIMPLANT 18?
SIMPLANT 18 is a medical device that received FDA 510(k) clearance on 2018-04-04. It is manufactured by Dentsply Sirona. The 510(k) number is K172239.
When was SIMPLANT 18 approved by the FDA?
SIMPLANT 18 received FDA 510(k) clearance on 2018-04-04, under approval number K172239.
What company makes SIMPLANT 18?
SIMPLANT 18 is manufactured by Dentsply Sirona.
What is the FDA product code for SIMPLANT 18?
The FDA product code for SIMPLANT 18 is LLZ.
Other Devices by Dentsply Sirona
Related Devices (Code: LLZ)
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.