septodont.comOraverse
Phentolamine Mesylate
SEPTODONT HEALTHCARE INDIA PRIVATE LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004443427 | 3004443427 | SEPTODONT HEALTHCARE INDIA PRIVATE LTD. | 1 | N | 2026-01-01 | C-1/2 MIDC INDUSTRIAL AREA TALOJA VILLAGE-NAVADE, TALUKA-PANVEL Maharashtra IN 410208 |
| 3008242564 | 3008242564 | Septodont, Inc | 1 | Y | 2026-01-01 | 205 Granite Run Dr., Suite 150 Lancaster PA US 17601 |
| 1721729 | 1721729 | Septodont, Inc. | 1 | Y | 2020-04-25 | 416 S Taylor Ave LOUISVILLE CO US 80027 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00303620000628 | SEPTODONT ETCH 4 X 4GM KIT - 01C2032 | (303) 665-7535 | usregulatoryaffairs@septodont.com |
| 00303620000635 | SEPTODONT USA SEPTOETCH 12-1.6GM SYR - 01C2034 | (303) 665-7535 | usregulatoryaffairs@septodont.com |
| 00303620000642 | SEPTODONT ETCHANT 60GM SYR KIT - 01C2035 | (303) 665-7535 | usregulatoryaffairs@septodont.com |
| 00303620000857 | SEPTODONT HZ IMAGE MH COMP L/C SYR KIT - 01C2080 | (303) 665-7535 | usregulatoryaffairs@septodont.com |
| 03760140703243 | CIMPAT PINK - Temporary filling material | (303) 665-7535 | usregulatoryaffairs@septodont.com |
| 03760140703359 | RACEGEL - Thermo-gelifiable gel for gingival preparation | (303) 665-7535 | usregulatoryaffairs@septodont.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 45712 | 1358624942 | K992727 | THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM | KIF | 2000-01-18 |
| 45712 | 1424117463 | K990779 | HEMASEAL & CIDE | LBH | 1999-11-17 |
| 45712 | 1072571331 | K955328 | CONFI-BOND | KLE | 1996-03-28 |
| 45712 | 1645185661 | K954988 | CRYSTALLESSENCE | EBF | 1996-03-08 |
| 238145 | 1065341210 | K952930 | DENTRAY II PLUS TRAY ADHESIVE | ELW | 1995-09-08 |
| 45712 | 1065341210 | K952930 | DENTRAY II PLUS TRAY ADHESIVE | ELW | 1995-09-08 |
| 45712 | 1680604303 | K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | EBF | 1995-01-26 |
| 45712 | 1304922243 | K940546 | GRANITEC IONOMER RESIN CEMENT | EMA | 1994-04-29 |
| 45712 | 1424987077 | K935714 | CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE | DYH | 1994-01-21 |
| 45712 | 1280769535 | K933199 | CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL | EMA | 1994-01-06 |
| 45712 | 1370624292 | K932002 | BARITONE C2, MODIFICATION | EBC | 1993-07-22 |
| 45712 | 1678680957 | K931857 | SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT | EBC | 1993-07-22 |
| 45712 | 1058153247 | K925359 | RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS | DYH | 1993-07-08 |
| 45712 | 1093437440 | K922252 | TI-CORE NEW & IMPROVED | EBF | 1994-01-26 |
| 45712 | 2008188106 | K922251 | TI-CORE-NATURAL | EBF | 1994-01-26 |
| 45712 | 2012639307 | K922250 | FLEXI-FLOW CEMENT WITH TITANIUM | EMA | 1994-01-26 |
| 45712 | 1983705442 | K922249 | FLEXI-FLOW CEMENT NATURAL | EMA | 1994-01-26 |
| 45712 | 1103947416 | K920534 | PORCELAIN PRIMER | DYH | 1992-03-26 |
| 45712 | 1726315210 | K920533 | DENTIN BONDING AGENT | EBF | 1993-05-19 |
| 45712 | 2069599145 | K915467 | CIMPAT S DENTAL CEMENT | EMA | 1992-02-03 |
| 45712 | 1324578707 | K914325 | ROOT CANAL FILLING CEMENT | KIF | 1992-03-09 |
| 45712 | 1617930258 | K914322 | BARITONE C2 & BARITONE L3 | EBC | 1991-10-23 |
| 45712 | 1395465644 | K914318 | GLASS IONOMER CEMENT | EMA | 1992-03-20 |
| 45712 | 1599855026 | K914317 | ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL | DYH | 1992-03-26 |
| 45712 | 1959976838 | K902817 | SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST | EMA | 1990-08-28 |
| 45712 | 1420819220 | K902635 | MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS | EMA | 1990-07-10 |
| 45712 | 1297692379 | K896649 | GRANITEC Z2, ZINC PHOSPHATE CEMENT | EMA | 1990-02-22 |
| 45712 | 1465218262 | K894890 | CRYSTALLINE C2 AND CRYSTALLINE L3 | EBF | 1989-10-27 |
| 45712 | 1882165827 | K891463 | ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM | EBF | 1989-05-19 |
| 238145 | 2065456278 | K870147 | CARERITE & COST RITE NYLON STERILIZATION FILM | FRG | 1987-04-23 |
| 45712 | 2065456278 | K870147 | CARERITE & COST RITE NYLON STERILIZATION FILM | FRG | 1987-04-23 |
| 9037 | 1433694594 | K172839 | ENDOSOLV | KIF | 2018-02-13 |
| 45712 | 1289040507 | K130601 | BIOROOT RCS | KIF | 2013-10-17 |
| 45712 | 1142653599 | K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | DYH | 2012-05-21 |
| 45712 | 1175359610 | K120283 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT | EMA | 2012-07-31 |
| 45712 | 1845895882 | K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | 2011-05-17 |
| 45712 | 1088084958 | K110058 | BPA-FREE PIT AND FISSURE SEALANT | EBC | 2011-03-31 |
| 45712 | 1785442474 | K101540 | GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE | EBF | 2010-10-29 |
| 238145 | 1571422964 | K092943 | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | EJI | 2009-12-11 |
| 45712 | 1571422964 | K092943 | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | EJI | 2009-12-11 |
| 45712 | 1387649441 | K072150 | DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL | EBF | 2007-09-13 |
| 45712 | 1682306644 | K063856 | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM | KIF | 2007-02-06 |
| 238145 | 1378806154 | K051291 | NON-STERILE SURGICAL MASK | FXX | 2005-09-20 |
| 45712 | 1378806154 | K051291 | NON-STERILE SURGICAL MASK | FXX | 2005-09-20 |
| 45712 | 1258714600 | K042614 | S&C-SELF ETCH PR-BOND | KLE | 2004-11-22 |
| 238145 | 1258714600 | K042614 | S&C-SELF ETCH PR-BOND | KLE | 2004-11-22 |
| 9037 | 1932441018 | K032708 | PLASTALGIN AND PLASTALGIN ORTHO | ELW | 2003-11-20 |
| 45712 | 1708576893 | K030807 | CARIES INDICATOR | LFC | 2003-06-09 |
| 45712 | 1800219453 | K030743 | ETCHANT 40% | KLE | 2003-05-09 |
| 45712 | 1824999639 | K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | EJI | 2000-10-13 |
| 238145 | 1824999639 | K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | EJI | 2000-10-13 |
| 45712 | 1516156464 | ||||
| 45712 | 1754269956 | ||||
| 45712 | 1853039213 | ||||
| 45712 | 1995269769 | ||||
| 238145 | 1995269769 | ||||
| 45712 | 2011883422 | ||||
| 238145 | 2011883422 | ||||
| 238145 | 1754269956 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EMA | 10 | 2012-07-31 |
| EBF | 9 | 2010-10-29 |
| KIF | 5 | 2018-02-13 |
| DYH | 5 | 2012-05-21 |
| EBC | 4 | 2011-03-31 |
| EJI | 4 | 2009-12-11 |
| KLE | 4 | 2004-11-22 |
| ELW | 3 | 2003-11-20 |
| FXX | 2 | 2005-09-20 |
| FRG | 2 | 1987-04-23 |
| EBG | 1 | 2011-05-17 |
| LFC | 1 | 2003-06-09 |
| LBH | 1 | 1999-11-17 |
NDC#
Lidocaine
Lidocaine
Lidocaine
Lidocaine Hydrochloride and Epinephrine
Marcaine
bupivacaine hydrochloride and epinephrine bitartrate
Carbocaine
Mepivacaine Hydrochloride
Zorcaine
Articaine Hydrochloride and Epinephrine
Lidocaine
Lidocaine Hydrochloride and Epinephrine
Lignospan Standard
Lidocaine Hydrochloride and Epinephrine
Lignospan Forte
Lidocaine Hydrochloride and Epinephrine
Scandonest 3% Plain
Mepivacaine Hydrochloride
Flavalta
Lidocaine Hydrochloride and Epinephrine
DycloPro
Dyclonine Hydrochloride
Vivacaine
bupivacaine hydrochloride and epinephrine bitartrate
Septocaine and Epinephrine
Articaine Hydrochloride and Epinephrine Bitartrate
Septocaine and Epinephrine
Articaine Hydrochloride and Epinephrine Bitartrate
PMN#
BioRoot Flow 0.5g, BioRoot Flow 2g
Septodont
Biodentine XP 500, Biodentine XP 200
Septodont
ENDOSOLV
Septodont
BIODENTINE
SEPTODONT
RACEGEL
SEPTODONT
BIODENTINE
SEPTODONT
RTR SYRINGE
SEPTODONT
PLASTALGIN AND PLASTALGIN ORTHO
SEPTODONT
ACROSEAL ROOT CANAL OR APICAL SEALER
Septodont S.A.S.
ENDOSOLV E
SEPTODONT, INC.
NEUTROCIM
SEPTODONT, INC.
FLUOCAL GEL MINT
SEPTODONT, INC.
FLUOCAL GEL ORANGE
SEPTODONT, INC.
RACESTYPTINE RINGS
SEPTODONT, INC.
CALCIPULPE
SEPTODONT, INC.
DETARTRINE P
SEPTODONT, INC.
HYDROL
SEPTODONT, INC.
RACESTYPTINE CORD
SEPTODONT, INC.
Applications#
GUDID#
SEPTODONT ETCH 4 X 4GM KIT - 01C2032
2016-09-12
SEPTODONT USA SEPTOETCH 12-1.6GM SYR - 01C2034
2016-09-12
SEPTODONT ETCHANT 60GM SYR KIT - 01C2035
2016-09-12
SEPTODONT HZ IMAGE MH COMP L/C SYR KIT - 01C2080
2016-09-12
Septodont Multi-Use Dispenser - multi-use dispenser
2025-05-29
Biodentine Mixer - cartridge mixer
2025-04-25
RACEGEL - Thermo-gelifiable gel for gingival preparation
2016-09-12
CIMPAT PINK - Temporary filling material
2016-09-12
CIMPAT WHITE - Temporary filling material
2016-09-12
SeptoWedges Refill: 100 wooden wedges n°1-yellow - wooden wedges
2022-12-19
SeptoWedges Refill: 100 Asst. wooden wedges - wooden wedges
2022-12-19
SeptoMatrix Sectional Refill: 50 assorted matrices - Preformed sectional matrices systems for Class II restorations.
2022-12-16
SeptoMatrix Sectional Refill: 50 large matrices - Preformed sectional matrices systems for Class II restorations.
2022-12-16
SeptoMatrix Sectional Refill: 50 medium matrices - Preformed sectional matrices systems for Class II restorations.
2022-12-16
SeptoMatrix Sectional Refill: 50 small matrices - Preformed sectional matrices systems for Class II restorations.
2022-12-16
SeptoPlus Mandrel Refill: 1 mandrel snap - Mandrel for contra angle
2022-12-19
SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on - Finishing and polishing discs for composites
2022-12-16
SeptoDiscs Refill:1/2” 50 assorted abrasive discs - Finishing and polishing discs for composites
2022-12-16
SeptoDiscs Refill:1/2” 50 coarse abrasive discs - Finishing and polishing discs for composites
2022-12-16
SeptoDiscs Refill:1/2” 50 medium abrasive discs - Finishing and polishing discs for composites
2022-12-16
SeptoDiscs Refill: 1/2” - 50 fine abrasive discs - Finishing and polishing discs for composites
2022-12-16
SeptoDiscs Refill: 1/2” - 50 extra fine abrasive discs - Finishing and polishing discs for composites
2022-12-16
SeptoWedges Refill: 100 wooden wedges n°2-blue - wooden wedges
2022-12-19
SeptoWedges Refill: 100 wooden wedges n°3-red - wooden wedges
2022-12-19
SeptoWedges Refill: 100 wooden wedges n°4-violet - wood wedges
2022-12-19
SeptoWedges Refill: 100 wooden wedges n°5 natural - wood wedges
2022-12-19
SeptoWheels PX Kit: 12 wheels + 1 mandrel snap on - Finishing and polishing material
2022-12-16
SEPTODONT IMAGE MH L/C REFILL SYRINGE BW - 01C2093
2016-09-12
Biodentine Applicator (Gun) - Device for extrusion of dentine substitute.
2024-12-01
Biodentine Applicator (Gun) - Device for extrusion of dentine substitute.
2024-12-01
R.T.R Membrane - Absorbable Collagen Membrane (15X20MM) for dental surgery.
2017-07-14
R.T.R Membrane - Absorbable Collagen Membrane (30X40MM) for dental surgery.
2017-07-14
R.T.R Membrane - Absorbable Collagen Membrane (20X30MM) for dental surgery
2017-07-14
BIODENTINE - 5 PACK - Bioactive dentin substitute
2016-09-12
BIODENTINE - Bioactive dentin substitute
2016-09-12
SeptoFipo Strips , box of 100, 2.5mm - aluminum oxide polyester strip
2022-12-20
Orasoothe Oral Coating Rinse 4oz – Hygiene - dressing wound
2022-12-19
Orasoothe Oral Coating Rinse 4oz – Professional - dressing wound
2022-12-19
Orasoothe Sockit Gel Syringe-25 pk - dressing wound
2022-12-19
Orasoothe Sockit Gel Syringe - dressing wound
2022-12-19