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FDA 510(k)

DENTCA DENTURE Teeth

K-Number: K172398 · 2017-11-22

ApplicantDentca, Inc.
Decision Date2017-11-22
Product CodePZY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTCA DENTURE Teeth is a medical device manufactured by Dentca, Inc.. It received FDA 510(k) clearance on 2017-11-22 under approval number K172398. The device is classified under product code PZY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTCA DENTURE Teeth?

DENTCA DENTURE Teeth is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Dentca, Inc.. The 510(k) number is K172398.

When was DENTCA DENTURE Teeth approved by the FDA?

DENTCA DENTURE Teeth received FDA 510(k) clearance on 2017-11-22, under approval number K172398.

What company makes DENTCA DENTURE Teeth?

DENTCA DENTURE Teeth is manufactured by Dentca, Inc..

What is the FDA product code for DENTCA DENTURE Teeth?

The FDA product code for DENTCA DENTURE Teeth is PZY.

Related Clinical Trials

NCT07585162 PRINTOW: Occlusal Wear of Denture Teeth in Digitally Fabricated Complete Dentures NOT_YET_RECRUITING

Other Devices by Dentca, Inc.

K162044Dentca Denture Base II K192806DENTCA Crown and Bridge K220042Dentca Base Premium, Dentca Base Hi-Impact

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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