FDA.reportPublic FDA data

PARKELL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24117972411797PARKELL, INC.1Y2026-01-01300 EXECUTIVE DR. EDGEWOOD NY US 11717

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810000522729GentleCLEAN™ - Pink Soft-Grip 30k GentleCLEAN™ Ultrasonic Scaler Insert6312491134customerservice@parkell.com
00810000529568TotalBond® - TotalBond® MTL-V Primer 3ml.6312491134customerservice@parkell.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1996061953698013K991270SMARTEMPEBG1999-05-21
1996061587389179K974865CSREBI1998-03-16
1996061208765322K973976EPIC-FLOEBF1997-12-04
1996061698528547K973679AEROETCHERKOJ1998-03-10
1996061424313334K964867HYBRID RESIN COMPOSITEKLE1997-04-11
1996061089367782K962741TRI-PHASIX CHROMATIC ALGINATEELW1996-09-06
1996061494016644K960879AMALGAMIBOND PLUSKLE1996-03-22
1996061101721223K960464C & B METABOND (MODIFICATION)EMA1996-02-26
1996061239622450K952123MS EMULSIONKLE1995-06-20
1996061145464122K950256TURBO 25/30ELC1995-04-04
1996061331065512K950239SENSIMATIC 500SEEKZ1995-06-06
1996061707080777K950238GENTAL PULSEEAT1995-05-09
1996061617297521K942017V-PRIMERKLE1994-07-06
1996061979396792K923867METAFILEBF1992-10-06
1996061750721331K905032MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIALELW1991-03-15
1996061087388476K900303CONNECTEMA1990-04-12
1996061155606227K896719PRIMER-P ADHESIVE AGENTEBI1990-02-22
1996061617241607K822896CAVIDRYEJH1982-10-22
1996061698032793K771527ACCU. CROWN COLD CUREEBG1977-08-16
1996061431927936K210259Parkell Self-Adhesive CementEMA2022-01-20
1996061212282192K191103Parkell Desensitizer GelEJK2019-11-22
1996061299512867K182296HyperFil-LVEBF2018-12-14
1996061616432960K172176Parkell Universal AdhesiveKLE2017-11-21
1996061872184599K151518BRUSH&BOND PLUSKLE2015-09-18
1996061461618935K142848EAZY PRIMERKLE2015-02-24
1996061469671215K113839RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTEMVL2012-04-12
1996061786825858K101044RETRIEVE IMPLANT CEMENTEMA2010-06-10
1996062068655846K073698SECUREEMA2008-03-19
1996061578859933K063003AURORAEBZ2006-11-28
1996061027741718K060946CZ-S2000KIF2006-06-15
1996062062025793K053516MUCOHARDEBI2006-01-26
1996061626422884K040599PARKELL RESIN GLAZEEBD2004-04-09
1996062039164855K020239TOUCH&BOND-PLUSKLE2002-03-20
1996061709718455K010475D/C CORE MATERIALEBF2001-05-07
1996061533152723K003221HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POSTELR2000-10-25
1996061279261756K002195FORAMATRON V, MODEL D680LQY2000-08-30
1996061035480838
1996061046068293
1996061312583935
1996061417280294
1996061476487850
1996061532546866
1996061537830040
1996061558880554
1996061594511952
1996061799124630
1996061946006826

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KLE82017-11-21
EMA52022-01-20
EBF42018-12-14
EBI32006-01-26
EBG21999-05-21
ELW21996-09-06
EJK12019-11-22
MVL12012-04-12
EBZ12006-11-28
KIF12006-06-15
EBD12004-04-09
ELR12000-10-25
LQY12000-08-30
KOJ11998-03-10
EKZ11995-06-06
EAT11995-05-09
ELC11995-04-04
EJH11982-10-22

PMN#

CSR

1998-03-16

PARKELL, INC.

ABOND

1995-06-20

PARKELL, INC.

54 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next