HomeUSADENT ZAR, INC.

DENT ZAR, INC.

USA · Canoga Park
✓ 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
9listed device types
Class I 3Class II 6Class III 0
plus 22 registration records and 12 510(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
1active device licences
Class III 1
8 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 States22 registration records, 12 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: DENT ZAR, INC. · DENT ZAR INTERNATIONAL INC.
Same-named companies — This database also contains companies with near-identical names: DENT ZAR INTERNATIONAL INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Canoga Park

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

21989
101996 · K962277

FDA listed device types

showing 8 of 9
Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Adhesive, Bracket And Tooth Conditioner, Resin 1Material, Tooth Shade, Resin 1Crown And Bridge, Temporary, Resin 1Agent, Tooth Bonding, Resin 1Light, Fiber Optic, Dental 1Agent, Polishing, Abrasive, Oral Cavity 1

Registration details (sample)

MarketIdentifierNameClass / date
USK962277SELF CURE BONDING AGENT1996-07-03
USK960597ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE1996-04-26
USK960594LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS1996-04-26
CA19152FRONTIER - CROWN AND BRIDGE CEMENTSClass III

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