CreoDent Solidex Custom Abutment
K-Number: K160436 · 2016-09-29
ApplicantCreodent Prosthetics, Ltd.
Decision Date2016-09-29
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CreoDent Solidex Custom Abutment is a medical device manufactured by Creodent Prosthetics, Ltd.. It received FDA 510(k) clearance on 2016-09-29 under approval number K160436. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CreoDent Solidex Custom Abutment?
CreoDent Solidex Custom Abutment is a medical device that received FDA 510(k) clearance on 2016-09-29. It is manufactured by Creodent Prosthetics, Ltd.. The 510(k) number is K160436.
When was CreoDent Solidex Custom Abutment approved by the FDA?
CreoDent Solidex Custom Abutment received FDA 510(k) clearance on 2016-09-29, under approval number K160436.
What company makes CreoDent Solidex Custom Abutment?
CreoDent Solidex Custom Abutment is manufactured by Creodent Prosthetics, Ltd..
What is the FDA product code for CreoDent Solidex Custom Abutment?
The FDA product code for CreoDent Solidex Custom Abutment is NHA.
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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.