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FDA 510(k)

Prettau, ICE, Z-White zirconia blanks

K-Number: K183304 · 2019-04-04

ApplicantZirkonzahn Srl
Decision Date2019-04-04
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Prettau, ICE, Z-White zirconia blanks is a medical device manufactured by Zirkonzahn Srl. It received FDA 510(k) clearance on 2019-04-04 under approval number K183304. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prettau, ICE, Z-White zirconia blanks?

Prettau, ICE, Z-White zirconia blanks is a medical device that received FDA 510(k) clearance on 2019-04-04. It is manufactured by Zirkonzahn Srl. The 510(k) number is K183304.

When was Prettau, ICE, Z-White zirconia blanks approved by the FDA?

Prettau, ICE, Z-White zirconia blanks received FDA 510(k) clearance on 2019-04-04, under approval number K183304.

What company makes Prettau, ICE, Z-White zirconia blanks?

Prettau, ICE, Z-White zirconia blanks is manufactured by Zirkonzahn Srl.

What is the FDA product code for Prettau, ICE, Z-White zirconia blanks?

The FDA product code for Prettau, ICE, Z-White zirconia blanks is EIH.

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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.

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