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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 the device name listed in this FDA 510(k) record. The listed applicant is Dentca, Inc.. It received FDA 510(k) clearance on 2017-11-22 under 510(k) 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. The listed applicant is Dentca, Inc.. The 510(k) number is K172398.

When did DENTCA DENTURE Teeth receive FDA 510(k) clearance?

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

Who is the listed applicant for DENTCA DENTURE Teeth?

The FDA 510(k) record lists Dentca, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTCA DENTURE Teeth?

The FDA product code for DENTCA DENTURE Teeth is PZY.

Other records listing Dentca, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261474DENTCA Tru FlexibleK220042Dentca Base Premium, Dentca Base Hi-ImpactK192806DENTCA Crown and BridgeK162044Dentca Denture Base II

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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