PURE Ceramic Implants
K-Number: K151328 · 2016-01-11
ApplicantStraumann USA
Decision Date2016-01-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PURE Ceramic Implants is a medical device manufactured by Straumann USA. It received FDA 510(k) clearance on 2016-01-11 under approval number K151328. 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 PURE Ceramic Implants?
PURE Ceramic Implants is a medical device that received FDA 510(k) clearance on 2016-01-11. It is manufactured by Straumann USA. The 510(k) number is K151328.
When was PURE Ceramic Implants approved by the FDA?
PURE Ceramic Implants received FDA 510(k) clearance on 2016-01-11, under approval number K151328.
What company makes PURE Ceramic Implants?
PURE Ceramic Implants is manufactured by Straumann USA.
What is the FDA product code for PURE Ceramic Implants?
The FDA product code for PURE Ceramic Implants is DZE.
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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.