FDA.reportPublic FDA data

DENTALEZ, INC., STARDENTAL DIVISION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25202652520265DENTALEZ, INC., STARDENTAL DIVISION1N2027-01-011816 Colonial Village Ln Lancaster PA US 17601

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
75991299002679K990954ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SETEBW1999-06-09
75991057841146K983574STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTSEGS1999-01-08
75991675732072K982593LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIEEFB1998-10-22
75991297598003K962540E-TYPE CONTRA ANGLE NAC-EEGS1996-09-12
75991978481264K944271DENTAL OPERATIVE UNIT ACCESORIESEIA1994-12-29
75991376842551K896361HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATUREEFB1990-02-02
75991194356770K881253ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SWELC1988-04-21
75991809421497K251701Star E900 Electric SystemEBW2026-01-12
75991646881047K240183Star E900 Handpiece SeriesEGS2024-09-19
75992047614850K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed HandpieceEFB2020-01-06
75991374785597K182999General Cutting Contra HandpieceEGS2019-04-16
75991556359463K163483PANA SPRAY PlusEFB2017-08-15
75991168341481K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed HandpieceEFB2016-04-08
75991093613632K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEM2016-03-03
75991284109472K132356SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40STEGS2014-01-31
75991389867859K131578IPROPHY MOBILEEKX2013-09-12
75991077978474K130455430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECESEFB2013-09-25
75991798123634K113301CONCENPIECE,HIGH-SPEED HANDPIECE SERIESEFB2012-01-23
75991503873607K090937E-STATIS 40 SYSTEMEBW2009-07-24
75991972115875K090135TRIMIRA IDENTAFI 3000NXV2009-02-17
75991931345664K083252NUTORQUE PROGRAMMABLE ELECTRIC SYSTEMEBW2009-02-18
75991729186265K070869PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422EFB2007-06-15
75991607601668
75991842112862
75991183300439
75991260107032
75991314572647
75991506256642
75991535662234
75991557564344
75991863051058
75992001878018

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EFB82020-01-06
EGS52024-09-19
EBW42026-01-12
PEM12016-03-03
EKX12013-09-12
NXV12009-02-17
EIA11994-12-29
ELC11988-04-21

PMN#