ZenSeal Pro
Kerr Corporation
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2024312 | 2024312 | Kerr Corporation | 1 | Y | 2026-01-01 | 1717 W Collins Ave ORANGE CA US 92867 |
| 8020994 | 1000231788 | Kerr Italia, S.r.l. | 1 | N | 2026-01-01 | Via Passanti, 174 SCAFATI Salerno IT 84018 |
| 3002807267 | 3002807267 | Kerrie Campbell | 1 | N | 2026-01-01 | 5010 Campuswood Dr, Ste 102 East Syracuse NY US 13057 |
| 3005545216 | 3005545216 | Kerry Rome | 1 | N | 2026-01-01 | 1525 Bluegrass LakesParkway, Suite B Alpharetta GA US 30004 |
| 3006697299 | 3006697299 | Kerri DiPietro | 1 | N | 2026-01-01 | 11 Cabot Blvd Mansfield MA US 02048 |
| 3006845687 | 3006845687 | Kerry Edgar | 1 | N | 2026-01-01 | 18001 Sky Park Cir Ste E-F Irvine CA US 92614 |
| 3012352782 | 3012352782 | Kerry Rome | 1 | N | 2026-01-01 | 1525 Bluegrass LakesParkway, Suite B Alpharetta GA US 30004 |
| 3012477813 | 3012477813 | Kerr Corporation | 1 | Y | 2026-01-01 | 1889 W Mission Blvd Pomona CA US 91766 |
| 3013886523 | 3013886523 | Kerri DiPietro | 1 | N | 2026-01-01 | 11 Cabot Blvd Mansfield MA US 02048 |
| 3021039857 | 3021039857 | Kerrie Campbell | 1 | N | 2026-01-01 | 5010 Campuswood Dr, Ste 102 East Syracuse NY US 13057 |
| 3032378317 | 3032378317 | Kerr Corporation | 1 | N | 2026-01-01 | 1937 W Mission Blvd Pomona CA US 91766 |
| 1815757 | 1815757 | Kerr Corporation | 1 | Y | 2020-04-25 | 28200 Wick Rd Romulus MI US 48174 |
| 3005426761 | 3005426761 | Kerry Pearson | 1 | N | 2020-04-25 | 11621 Research Cir, Alachua, FL 32615 Alachua FL US 32615 |
| 3013221323 | 3013221323 | Kerrie Jiang | 1 | N | 2020-04-25 | 4410 Rosewood Drive Pleasanton CA US 94588 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00195062145247 | ZenFlex CM - .13/.06/25mm ZenFlex CM NiTi FILE REFILL PACK | 1-800-537-7123 | kerrcustcare@kavokerr.com |
| 00195062145254 | ZenFlex CM - .13/.06/31mm ZenFlex CM NiTi FILE REFILL PACK | 1-800-537-7123 | kerrcustcare@kavokerr.com |
| 00195062145261 | ZenFlex CM - .15/.06/21mm ZenFlex CM NiTi FILE REFILL PACK | 1-800-537-7123 | kerrcustcare@kavokerr.com |
| 00195062145278 | ZenFlex CM - .15/.06/25mm ZenFlex CM NiTi FILE REFILL PACK | 1-800-537-7123 | kerrcustcare@kavokerr.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 116568 | 1377515037 | P110008 | COFLEX® INTERLAMINAR TECHNOLOGY | NQO | 2012-10-17 |
| 16973 | 1316781385 | K992484 | RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG | KJJ | 1999-10-14 |
| 192911 | 1316781385 | K992484 | RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG | KJJ | 1999-10-14 |
| 210808 | 1428097792 | K992173 | SIPHONGUARD CSF CONTROL DEVICE | JXG | 2000-04-07 |
| 16969 | 1388384955 | K991808 | OPTIBOND SOLO PLUS 2 | KLE | 1999-07-09 |
| 16973 | 1388384955 | K991808 | OPTIBOND SOLO PLUS 2 | KLE | 1999-07-09 |
| 210808 | 1088532226 | K991413 | CODMAN ETHISORB DURA PATCH | GXQ | 2000-03-13 |
| 16973 | 1433148363 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | EKX | 1999-03-24 |
| 16973 | 1390104932 | K990225 | ENDO ANALYZER, MODEL 8005, MODIFIED | EAT | 1999-02-25 |
| 16973 | 1694946290 | K984483 | A-SOFT RELINER | EBI | 1999-02-18 |
| 18417 | 1397905368 | K983610 | CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 | CAH | 1999-04-30 |
| 16973 | 1080547800 | K983266 | FIBREKOR POST SYSTEM | ELR | 1998-11-09 |
| 192911 | 1080547800 | K983266 | FIBREKOR POST SYSTEM | ELR | 1998-11-09 |
| 330454 | 1080547800 | K983266 | FIBREKOR POST SYSTEM | ELR | 1998-11-09 |
| 16973 | 1100827861 | K982148 | PRODIGY 2 | EBF | 1998-07-31 |
| 44641 | 1408053185 | K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | 1998-07-06 |
| 16973 | 1721040002 | K974131 | ALERT | EBF | 1997-12-17 |
| 210808 | 1839003887 | K974088 | CODMAN INTRACRANIAL BOLT | GWM | 1998-01-09 |
| 210808 | 1505347487 | K973774 | CODMAN HAKIM MICRO PRECISION VALVE | JXG | 1997-12-29 |
| 16973 | 1551645059 | K973388 | DENTIN CONDITIONING AND ADHESIVE (BOND 1) | KLE | 1997-09-12 |
| 16973 | 1939354738 | K970715 | SYSTEM B HEAT SOURCE | EAT | 1997-04-07 |
| 192911 | 1939354738 | K970715 | SYSTEM B HEAT SOURCE | EAT | 1997-04-07 |
| 16973 | 1848577616 | K963862 | TOUCH N' HEAT | EAT | 1996-12-02 |
| 192911 | 1848577616 | K963862 | TOUCH N' HEAT | EAT | 1996-12-02 |
| 44641 | 1214703546 | K962928 | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) | GWM | 1996-12-20 |
| 192911 | 1443680802 | K962540 | E-TYPE CONTRA ANGLE NAC-E | EGS | 1996-09-12 |
| 192911 | 1896324869 | K962288 | COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER | MMP | 1997-01-30 |
| 16973 | 1108521024 | K961284 | KOLOR + | EBF | 1996-05-08 |
| 192911 | 1532123031 | K960352 | ALLRAP/SLIP-N-GRIP | EFB | 1996-02-21 |
| 16973 | 1854747207 | K955932 | EXAFLEX IMPRESSION MATERIAL (MODIFICATION) | ELW | 1996-03-11 |
| 53185 | 1854747207 | K955932 | EXAFLEX IMPRESSION MATERIAL (MODIFICATION) | ELW | 1996-03-11 |
| 192911 | 1854747207 | K955932 | EXAFLEX IMPRESSION MATERIAL (MODIFICATION) | ELW | 1996-03-11 |
| 16973 | 1222090740 | K955331 | BELLEGLASHP | EBG | 1996-01-02 |
| 16973 | 1474511797 | K954827 | SEALITE FL | EBC | 1996-01-04 |
| 16969 | 1406887263 | K954708 | SILANE PRIMER | KLE | 1995-10-30 |
| 16973 | 1406887263 | K954708 | SILANE PRIMER | KLE | 1995-10-30 |
| 330454 | 1406887263 | K954708 | SILANE PRIMER | KLE | 1995-10-30 |
| 16973 | 1042565418 | K953859 | BOND-IT DUAL CURE ACTIVATOR | KLE | 1995-09-07 |
| 16969 | 1491902893 | K952662 | COMP=FLOW | EBF | 1995-08-28 |
| 16973 | 1491902893 | K952662 | COMP=FLOW | EBF | 1995-08-28 |
| 16973 | 1322350175 | K951663 | TYTIN R | EJJ | 1995-06-06 |
| 53185 | 1322350175 | K951663 | TYTIN R | EJJ | 1995-06-06 |
| 16969 | 1349518812 | K951238 | SAFE-TIPS EZ | EIA | 1995-05-23 |
| 16973 | 1743517692 | K945539 | OPTIGUARD | EBF | 1994-12-29 |
| 16973 | 1603276525 | K944659 | PRODIGY | EBF | 1994-12-08 |
| 210808 | 1185205031 | K944222 | CODMAN-MEDOS VALVE SHUNT SYSTEM | JXG | 1995-07-28 |
| 16973 | 2029594029 | K943642 | HERCULITE XR & XRV | EBF | 1994-11-17 |
| 16973 | 1486873553 | K936222 | DENTIN CONDITIONING AND ADHESIVE SYSTEM | KLE | 1994-03-15 |
| 16973 | 1427803211 | K935535 | TYTIN | EJJ | 1994-03-11 |
| 53185 | 1427803211 | K935535 | TYTIN | EJJ | 1994-03-11 |
| 16973 | 1160788427 | K934714 | ENDODONTIC PULP CANAL SPREADER | ELC | 1994-02-14 |
| 192911 | 1160788427 | K934714 | ENDODONTIC PULP CANAL SPREADER | ELC | 1994-02-14 |
| 66129 | 1906505641 | K931923 | DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) | GWF | 1993-11-09 |
| 66129 | 1370364746 | K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO | GWF | 1993-08-31 |
| 186467 | 1410423530 | K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO | GWF | 1993-08-31 |
| 18417 | 2012989113 | K925462 | BREATHING FILTERS 1942T/1941T/2014T | CAH | 1993-05-21 |
| 192911 | 1998637346 | K923556 | ADP FACEMASK | DZB | 1992-12-04 |
| 18417 | 1492156511 | K921512 | ENTENDED LINE ACCESSORIES & CONNECTORS | BZA | 1992-06-17 |
| 210808 | 2038978903 | K914479 | MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER | GWM | 1994-03-07 |
| 16973 | 1004779917 | K914178 | CORRECTED-V.P.S. | ELW | 1992-04-28 |
| 192911 | 1004779917 | K914178 | CORRECTED-V.P.S. | ELW | 1992-04-28 |
| 18417 | 1405342380 | K911427 | BREATHING FILTERS | CAH | 1991-08-26 |
| 18417 | 1928148300 | K911425 | ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM | BZA | 1991-06-24 |
| 18417 | 2072176961 | K911422 | DRUG NEBULIZERS | CAF | 1991-10-23 |
| 192911 | 1821428602 | K902646 | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP | DZB | 1990-09-06 |
| 192911 | 1990811308 | K902645 | HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL | DZB | 1990-09-06 |
| 16973 | 1773724308 | K894437 | PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH | FRG | 1990-01-10 |
| 16973 | 1612966479 | K874189 | DUAL-CURE RADIOPAQUE | EBF | 1988-02-11 |
| 44641 | 1845845260 | K864380 | LUTEX HEADLIGHT SYSTEMS | FST | 1986-11-19 |
| 192911 | 1860030203 | K843023 | KERR PORCELAIN REPAIR PRIMER | KLE | 1984-10-25 |
| 16973 | 1427846435 | K820181 | SYBRON/KERR CONTOUR | EJJ | 1982-02-24 |
| 53185 | 1427846435 | K820181 | SYBRON/KERR CONTOUR | EJJ | 1982-02-24 |
| 16969 | 1910254281 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | ELW | 1981-04-14 |
| 53185 | 1910254281 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | ELW | 1981-04-14 |
| 192911 | 1910254281 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | ELW | 1981-04-14 |
| 192911 | 1892759348 | K253461 | Demi Pro | EBZ | 2025-10-14 |
| 192911 | 1295097043 | K252890 | ZenSeal Pro | KIF | 2026-01-07 |
| 186467 | 1140799838 | K252032 | T65 (9016E061-) | OBP | 2025-07-30 |
| 66129 | 1759493123 | K252032 | T65 (9016E061-) | OBP | 2025-07-30 |
| 66129 | 1243464443 | K251125 | MagVenture TMS Therapy System | OBP | 2025-08-11 |
| 186467 | 1888637415 | K251125 | MagVenture TMS Therapy System | OBP | 2025-08-11 |
| 66129 | 1295853469 | K251119 | MagVenture TMS Therapy System | OBP | 2025-08-08 |
| 186467 | 1439238097 | K251119 | MagVenture TMS Therapy System | OBP | 2025-08-08 |
| 210808 | 1902114912 | K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | JXG | 2023-12-19 |
| 210808 | 1368725883 | K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | JXG | 2024-01-17 |
| 44641 | 1393210386 | K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | GWM | 2024-02-04 |
| 44641 | 1824474489 | K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2023-07-11 |
| 66129 | 1084677509 | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | QPL | 2023-08-25 |
| 186467 | 1121072309 | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | QPL | 2023-08-25 |
| 210808 | 1051015535 | K223330 | Certas Plus Programmable Valves | JXG | 2023-02-01 |
| 18417 | 1213373563 | K223258 | TNI Clear-Guard 3 angled breathing filter (1545020) | CAH | 2023-06-15 |
| 16969 | 1080632157 | K222830 | Rainbow 360 | KLE | 2023-01-12 |
| 16973 | 1080632157 | K222830 | Rainbow 360 | KLE | 2023-01-12 |
| 192911 | 1080632157 | K222830 | Rainbow 360 | KLE | 2023-01-12 |
| 210808 | 1457802808 | K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | JXG | 2022-10-14 |
| 44641 | 1746230866 | K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2022-08-22 |
| 44641 | 1942806843 | K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2022-07-15 |
| 186467 | 1512783775 | K221544 | MagVenture TMS Atlas Neuro Navigation System | HAW | 2023-03-17 |
| 66129 | 1631434781 | K221544 | MagVenture TMS Atlas Neuro Navigation System | HAW | 2023-03-17 |
| 16969 | 1713465672 | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | EBF | 2022-08-31 |
| 16973 | 1713465672 | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | EBF | 2022-08-31 |
| 192911 | 1713465672 | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | EBF | 2022-08-31 |
| 44641 | 1845126550 | K210993 | CereLink ICP Monitor | GWM | 2021-04-30 |
| 16973 | 1898191903 | K210789 | EQ-PEX | LQY | 2021-10-20 |
| 16973 | 1217130144 | K210475 | EQ-M | EKX | 2022-09-21 |
| 198355 | 1300633203 | K193566 | ZELTIQ CoolSculpting System | OOK | 2020-01-21 |
| 186467 | 1641721605 | K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system | QCI | 2020-08-09 |
| 66129 | 1956550121 | K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system | QCI | 2020-08-09 |
| 16973 | 1513389672 | K191548 | Nexus Universal Self-Cure | EMA | 2019-10-11 |
| 16973 | 1497170493 | K190503 | CeraSeal | KIF | 2019-06-07 |
| 44641 | 1670523884 | K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2019-04-01 |
| 44641 | 1755722249 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2018-12-07 |
| 210808 | 1878737732 | K182265 | CodMan Certas Plus Programmable Valve | JXG | 2018-11-20 |
| 16969 | 1659474519 | K182162 | OptiBond eXTRa Universal | KLE | 2018-11-07 |
| 16973 | 1659474519 | K182162 | OptiBond eXTRa Universal | KLE | 2018-11-07 |
| 44641 | 1216066706 | K181902 | Codman Certas Plus Electronic Tool Kit | JXG | 2018-10-25 |
| 198355 | 1016459560 | K181740 | ZELTIQ CoolSculpting System | OOK | 2018-08-29 |
| 186467 | 1458416510 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | OBP | 2018-08-14 |
| 66129 | 1934515121 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | OBP | 2018-08-14 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EBF | 50 | 2022-08-31 |
| ELW | 41 | 2016-08-05 |
| JXG | 32 | 2024-01-17 |
| KLE | 23 | 2023-01-12 |
| EMA | 19 | 2019-10-11 |
| OBP | 18 | 2025-08-11 |
| GWM | 17 | 2024-02-04 |
| GWF | 13 | 2017-03-31 |
| LFL | 10 | 2023-07-11 |
| CAH | 10 | 2023-06-15 |
| EBZ | 9 | 2025-10-14 |
| KIF | 8 | 2026-01-07 |
| EAT | 6 | 2002-06-19 |
| EJJ | 6 | 1995-06-06 |
| OOK | 5 | 2020-01-21 |
| MVL | 5 | 2017-08-08 |
| NQP | 5 | 2010-07-02 |
| EKX | 4 | 2022-09-21 |
| KJJ | 4 | 2003-03-05 |
| EBG | 4 | 2002-08-01 |
| ELC | 4 | 2002-07-05 |
| ELR | 4 | 1998-11-09 |
| LQY | 3 | 2021-10-20 |
| EJK | 3 | 2015-06-19 |
| DZP | 3 | 2012-04-20 |
| DZB | 3 | 1992-12-04 |
| QPL | 2 | 2023-08-25 |
| HAW | 2 | 2023-03-17 |
| QCI | 2 | 2020-08-09 |
| FRG | 2 | 2017-04-28 |
| EFA | 2 | 2017-03-17 |
| EBW | 2 | 2017-02-21 |
| GEI | 2 | 2016-12-01 |
| NYL | 2 | 2014-07-02 |
| KWP | 2 | 2012-02-13 |
| NKB | 2 | 2009-06-19 |
| HCA | 2 | 2003-05-14 |
| EBC | 2 | 2001-09-06 |
| BZA | 2 | 1992-06-17 |
| KCT | 1 | 2017-04-21 |
Kerr Corporation
Kerr Corporation
Kerr Corporation
Kerr Corporation
Kerr Corporation
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
Kerr Corporation
Kerr Corporation
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERRHAWE SA
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR CORP.
KERR CORPORATION
Kerr Corp.
Kerr Corp.
KERR CORPORATION
Kerr Corp.
KERR CORPORATION
KERR CORPORATION
KERR CORPORATION
KERR DENTAL MATERIALS CENTER
KERR CORPORATION (DANBURY)
KERR CORP.
KERR DENTAL MATERIALS CENTER
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