parkell.comLE CLEAN MACHINE
PARKELL, INC.
Parkell
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2411797 | 2411797 | PARKELL, INC. | 1 | Y | 2026-01-01 | 300 EXECUTIVE DR. EDGEWOOD NY US 11717 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810000522729 | GentleCLEAN™ - Pink Soft-Grip 30k GentleCLEAN™ Ultrasonic Scaler Insert | 6312491134 | customerservice@parkell.com |
| 00810000525799 | Predicta® - Predicta® Sealant - Pit & Fissure Sealant - Opaque White Shade | 631-249-1134 | customerservice@parkell.com |
| 00810000529193 | C&B METABOND® - ‘A’ Liquid Universal Dentin Activator 6ml. for C&B METABOND® & AMALGAMBOND® | 6312491134 | customerservice@parkell.com |
| 00810000529209 | C&B METABOND® - Enamel Etchant Gel (Red) 5ml. for C&B METABOND® | 6312491134 | customerservice@parkell.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 199606 | 1953698013 | K991270 | SMARTEMP | EBG | 1999-05-21 |
| 199606 | 1587389179 | K974865 | CSR | EBI | 1998-03-16 |
| 199606 | 1208765322 | K973976 | EPIC-FLO | EBF | 1997-12-04 |
| 199606 | 1698528547 | K973679 | AEROETCHER | KOJ | 1998-03-10 |
| 199606 | 1424313334 | K964867 | HYBRID RESIN COMPOSITE | KLE | 1997-04-11 |
| 199606 | 1089367782 | K962741 | TRI-PHASIX CHROMATIC ALGINATE | ELW | 1996-09-06 |
| 199606 | 1494016644 | K960879 | AMALGAMIBOND PLUS | KLE | 1996-03-22 |
| 199606 | 1101721223 | K960464 | C & B METABOND (MODIFICATION) | EMA | 1996-02-26 |
| 199606 | 1239622450 | K952123 | MS EMULSION | KLE | 1995-06-20 |
| 199606 | 1145464122 | K950256 | TURBO 25/30 | ELC | 1995-04-04 |
| 199606 | 1331065512 | K950239 | SENSIMATIC 500SE | EKZ | 1995-06-06 |
| 199606 | 1707080777 | K950238 | GENTAL PULSE | EAT | 1995-05-09 |
| 199606 | 1617297521 | K942017 | V-PRIMER | KLE | 1994-07-06 |
| 199606 | 1979396792 | K923867 | METAFIL | EBF | 1992-10-06 |
| 199606 | 1750721331 | K905032 | MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL | ELW | 1991-03-15 |
| 199606 | 1087388476 | K900303 | CONNECT | EMA | 1990-04-12 |
| 199606 | 1155606227 | K896719 | PRIMER-P ADHESIVE AGENT | EBI | 1990-02-22 |
| 199606 | 1617241607 | K822896 | CAVIDRY | EJH | 1982-10-22 |
| 199606 | 1698032793 | K771527 | ACCU. CROWN COLD CURE | EBG | 1977-08-16 |
| 199606 | 1131042835 | K243254 | Parkell Pit and Fissure Sealant | EBC | 2025-08-08 |
| 199606 | 1431927936 | K210259 | Parkell Self-Adhesive Cement | EMA | 2022-01-20 |
| 199606 | 1212282192 | K191103 | Parkell Desensitizer Gel | EJK | 2019-11-22 |
| 199606 | 1299512867 | K182296 | HyperFil-LV | EBF | 2018-12-14 |
| 199606 | 1616432960 | K172176 | Parkell Universal Adhesive | KLE | 2017-11-21 |
| 199606 | 1872184599 | K151518 | BRUSH&BOND PLUS | KLE | 2015-09-18 |
| 199606 | 1461618935 | K142848 | EAZY PRIMER | KLE | 2015-02-24 |
| 199606 | 1469671215 | K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | MVL | 2012-04-12 |
| 199606 | 1786825858 | K101044 | RETRIEVE IMPLANT CEMENT | EMA | 2010-06-10 |
| 199606 | 2068655846 | K073698 | SECURE | EMA | 2008-03-19 |
| 199606 | 1578859933 | K063003 | AURORA | EBZ | 2006-11-28 |
| 199606 | 1027741718 | K060946 | CZ-S2000 | KIF | 2006-06-15 |
| 199606 | 2062025793 | K053516 | MUCOHARD | EBI | 2006-01-26 |
| 199606 | 1626422884 | K040599 | PARKELL RESIN GLAZE | EBD | 2004-04-09 |
| 199606 | 2039164855 | K020239 | TOUCH&BOND-PLUS | KLE | 2002-03-20 |
| 199606 | 1709718455 | K010475 | D/C CORE MATERIAL | EBF | 2001-05-07 |
| 199606 | 1533152723 | K003221 | HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST | ELR | 2000-10-25 |
| 199606 | 1279261756 | K002195 | FORAMATRON V, MODEL D680 | LQY | 2000-08-30 |
| 199606 | 1035480838 | ||||
| 199606 | 1046068293 | ||||
| 199606 | 1312583935 | ||||
| 199606 | 1417280294 | ||||
| 199606 | 1476487850 | ||||
| 199606 | 1532546866 | ||||
| 199606 | 1537830040 | ||||
| 199606 | 1558880554 | ||||
| 199606 | 1594511952 | ||||
| 199606 | 1799124630 | ||||
| 199606 | 1946006826 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KLE | 8 | 2017-11-21 |
| EMA | 5 | 2022-01-20 |
| EBF | 4 | 2018-12-14 |
| EBI | 3 | 2006-01-26 |
| EBG | 2 | 1999-05-21 |
| ELW | 2 | 1996-09-06 |
| EBC | 1 | 2025-08-08 |
| EJK | 1 | 2019-11-22 |
| MVL | 1 | 2012-04-12 |
| EBZ | 1 | 2006-11-28 |
| KIF | 1 | 2006-06-15 |
| EBD | 1 | 2004-04-09 |
| ELR | 1 | 2000-10-25 |
| LQY | 1 | 2000-08-30 |
| KOJ | 1 | 1998-03-10 |
| EKZ | 1 | 1995-06-06 |
| EAT | 1 | 1995-05-09 |
| ELC | 1 | 1995-04-04 |
| EJH | 1 | 1982-10-22 |
PMN#
V-PRIMER
PARKELL, INC.
INTRA-ORAL IRRIGATOR
PARKELL, INC.
METAFIL
PARKELL
MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL
PARKELL
CONNECT
PARKELL
PRIMER-P ADHESIVE AGENT
PARKELL
HEMA-PRIMER
PARKELL
ABRAKADABRA - DENTAL ADHESIVE SYSTEM
PARKELL
PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER
PARKELL
COVER UP
PARKELL
ULTRASONIC TOOTH SCALER MODEL DSCIOP
PARKELL, INC.
SILAGUM
PARKELL, INC.
SAFE-T-PINS RETENTIVE PIN SYSTEM
PARKELL, INC.
GUDID#
Predicta® - 25-Guage Dispensing Tips for Predicta® Sealant
2026-09-25
Predicta® - Predicta® Sealant - Pit & Fissure Sealant - Opaque White Shade
2026-09-25
TotalBond® - TotalBond® MTL-V Primer 3ml.
2018-11-23
NA - MTL-V Primer 3ml.
2016-09-23
Epic® - C3 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules)
2016-09-23
GentleCLEAN™ - Pink Soft-Grip 30k GentleCLEAN™ Ultrasonic Scaler Insert
2018-11-02
C&B METABOND® - Enamel Etchant Gel (Red) 5ml. for C&B METABOND®
2018-11-23
C&B METABOND® - ‘A’ Liquid Universal Dentin Activator 6ml. for C&B METABOND® & AMALGAMBOND®
2018-11-23
C&B METABOND® - ‘A’ Gel Universal Dentin Activator 5ml. for C&B METABOND® & AMALGAMBOND®
2018-11-23
C&B METABOND® - Enamel Etchant Gel (Red) 5ml. for C&B METABOND®
2016-09-23
NA - ‘A’ Gel Universal Dentin Activator 5ml. for C&B METABOND® & AMALGAMBOND®
2016-09-23
NA - ‘A’ Liquid Universal Dentin Activator 6ml. for C&B METABOND® & AMALGAMBOND®
2016-09-23
Parkell® - Parkell® Etching Gel
2018-10-19
SmarTemp® - Dual Cure A2 (Light Shade) SmarTemp® in 50ml. Cartridge
2018-10-26
20/20™ - 20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.)
2025-09-26
TriPhasix™ - Measuring Scoops TriPhasix™ Alginate
2025-09-26
HyperFIL® - HyperFIL® + A2/B2
2025-09-26
20/20™ - 20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.)
2025-09-26
Parkell® - Parkell® Aluminum Oxide (50 micron) 5 Lbs.
2018-11-16
Aurora™ - Aluminum Oxide (50micron) 5 Lbs.
2016-09-24
DuraTip® - DuraTip® 30K Perio Right Insert
2025-07-18
DuraTip® - DuraTip® 30K Perio Left Insert
2025-07-18
HyperFIL® - HyperFIL® + A2/B2 - 10ml
2025-03-28
HyperFIL® - HyperFIL® + A1/B1 - 10ml
2025-03-28
HyperFIL® - HyperFIL® + A3/A3.5/B3 - 2.5ml
2025-03-28
Perio-Select - Handpiece w/Cable and Orange O-Ring for Perio-Select Scaler
2018-09-14
HyperFIL® - HyperFIL® + A2/B2 2.5ML
2024-03-01
HyperFIL® - HyperFIL® + A1/B1 - 2.5ML
2024-03-01
Gentle Pulse™ - Gentle Pulse™ Pulp Vitality Tester
2018-09-14
Gentle Pulse™ - Gentle Pulse™ Pulp Vitality Tester
2018-11-16
Foramatron® - The Foramatron® Electronic Apex Locator
2018-11-16
Dryz™ - Dryz™ BLU Unit-Dose Gingival Retraction Paste Sample (Contains; 3-Capsules)
2018-09-21
Dryz™ - Dryz™ Unit-Dose Gingival Retaction Paste Sample (Contains; 3-Capsules)
2018-09-21
TurboSENSOR™ - TurboSENSOR™ Ultrasonic Scaler 110 Volt
2020-02-07
Gentle Pulse™ - Gentle Pulse™ Pulp Vitality Tester (Korea)
2021-12-10
TurboSENSOR+™ - TurboSENSOR +™ 25/30K with removable sheath
2021-12-31
PerioSonic® - Empty Bottles for PerioSonic® Irrigator D583 & D584 (6 Bottles & Caps)
2018-11-16
Integra™ - Replacement Reservoir Bottles for Integra™ Scaler (2 Bottles & Caps)
2018-11-16
HyperFIL™ - 10ml Universal Shade HyperFIL™ - DC (Dual-Cure)
2018-10-26
TurboSENSOR +™ - TurboSENSOR +™ Detachable 30K (Tangerine)
2023-10-20