DENTCA, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3009312537

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009312537
FEI Number
3009312537
Entity Name
DENTCA, INC.
City/State/Country
Irvine, CA, US
Establishment Address
17742 Cowan, Irvine, CA 92614, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Dentca, Inc. (Owner Number: 10039139)
Owner / Operator Contact Address
17742 Cowan, Irvine, CA 92614, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220042
PMA Number
N/A

All Registered Proprietary Names

DENTCA Tray DENTCA Denture Base II/DENTCA Try-In DENTCA Design Pala Design Studio DENTCA Crown and Bridge DENTCA Base Hi-Impact DENTCA Base Premium

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2014-12-12
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2017-06-15
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2019-05-17
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2020-02-24
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2023-03-17

Official Correspondent

Jason Lee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dentca, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009312537. Last updated year: 2026. Please use registration number 3009312537 when referencing this establishment in official correspondence.
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