HomeUSALANG DENTAL MFG COMPANY INC

LANG DENTAL MFG COMPANY INC

USA · Wheeling
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Israel — 4 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
3listed device types
Class I 1Class II 2Class III 0
plus 13 registration records and 9 510(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
3active device licences
Class II 3
9 including historic records
TWTaiwanTFDA
11valid device licences
Class I 2Class II 9
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States13 registration records, 9 510(k), 0 PMA, 9 excluded
Brazil0 confirmed, 6 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada3 confirmed, 1 excluded
Manufacturer names merged into this page: LANG DENTAL MFG. CO., INC. · LANG DENTAL MFG COMPANY INC

Company information

Country
USA
City
Wheeling

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

11994
11997
12007
32008
12009
12010
12011

FDA listed device types

Crown And Bridge, Temporary, Resin 1Resin, Denture, Relining, Repairing, Rebasing 1Material, Impression Tray, Resin 1

Registration details (sample)

MarketIdentifierNameClass / date
USK112397ORTHO-JET CRYSTAL2011-11-04
USK100653JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD2010-10-08
USK083195MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN2009-06-05
CA4130BIS-JET TEMPORARY CROWN AND BRIDGE RESINClass II
CA7192SPLINTLINE TOOTH SHADEClass II
CA85113NOVUS DENTURE LINERClass II

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