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Home›USA›PRISMATIK DENTALCRAFT, INC.(A WHOLLY OWNED SUB. OF GLIDEWELL LAB.)

PRISMATIK DENTALCRAFT, INC.(A WHOLLY OWNED SUB. OF GLIDEWELL LAB.)

USA · Irvine
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
33listed device types
Class I 13Class II 18Class III 0unclassified 2
plus 85 registration records and 58 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
20 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States85 registration records, 58 510(k), 0 PMA
Manufacturer names merged into this page: PRISMATIK DENTALCRAFT, INC. · Prismatik Dentalcraft, Inc. · PRISMATIK DENTALCRAFT, INC.(A WHOLLY OWNED SUB. OF GLIDEWELL LAB.)
Same-named companies — This database also contains companies with near-identical names: PRISMATIK DENTALCRAFT, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Irvine

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

32010
32012
32013
72014
62015
42016
12017
32019
12020
32021
42022
62023
72024
52025
22026

FDA listed device types

showing 8 of 33
Bone Grafting Material, Animal Source 1Barrier, Animal Source, Intraoral 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Additively Manufactured, Preformed, Resin Denture Tooth 1Activator, Ultraviolet, For Polymerization 1Dental Abutment Design Software For Dental Laboratory 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1

Registration details (sample)

MarketIdentifierNameClass / date
USK262239Obsidian® Press Over Zirconia2026-07-30
USK254283BruxZir® Shaded 16 PLUS2026-01-30
USK252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems2025-11-18

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