Septodont, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1721729	1721729	Septodont, Inc.	1	Y	2020-04-25	416 S Taylor Ave LOUISVILLE CO US 80027

Registered Device Listings#

Registration key, Listing key, Premarket submission table
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
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
45712	2065456278	K870147	CARERITE & COST RITE NYLON STERILIZATION FILM	FRG	1987-04-23
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
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
45712	1378806154	K051291	NON-STERILE SURGICAL MASK	FXX	2005-09-20
45712	1258714600	K042614	S&C-SELF ETCH PR-BOND	KLE	2004-11-22
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
45712	1516156464
45712	1754269956
45712	1853039213
45712	1995269769
45712	2011883422

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EMA	10	2012-07-31
EBF	9	2010-10-29
DYH	5	2012-05-21
KIF	4	2013-10-17
EBC	4	2011-03-31
KLE	3	2004-11-22
EJI	2	2009-12-11
EBG	1	2011-05-17
FXX	1	2005-09-20
LFC	1	2003-06-09
LBH	1	1999-11-17
ELW	1	1995-09-08
FRG	1	1987-04-23

NDC#

Oraverse
Septodont, Inc.
Phentolamine Mesylate
Lidocaine
Septodont, Inc.
Lidocaine
Lidocaine
Septodont, Inc.
Lidocaine Hydrochloride and Epinephrine
Marcaine
Septodont, Inc.
bupivacaine hydrochloride and epinephrine bitartrate
Carbocaine
Septodont, Inc.
Mepivacaine Hydrochloride
Zorcaine
Septodont, Inc.
Articaine Hydrochloride and Epinephrine
Lidocaine
Septodont, Inc.
Lidocaine Hydrochloride and Epinephrine
Lignospan Standard
Septodont, Inc.
Lidocaine Hydrochloride and Epinephrine
Lignospan Forte
Septodont, Inc.
Lidocaine Hydrochloride and Epinephrine
Scandonest 3% Plain
Septodont, Inc.
Mepivacaine Hydrochloride
Flavalta
Septodont, Inc.
Lidocaine Hydrochloride and Epinephrine
Vivacaine
Septodont, Inc.
bupivacaine hydrochloride and epinephrine bitartrate

PMN#

ENDOSOLV E
1978-01-20
SEPTODONT, INC.
NEUTROCIM
1978-01-04
SEPTODONT, INC.
FLUOCAL GEL ORANGE
1976-11-24
SEPTODONT, INC.
FLUOCAL GEL MINT
1976-11-24
SEPTODONT, INC.
RACESTYPTINE RINGS
1976-11-19
SEPTODONT, INC.
RACESTYPTINE CORD
1976-09-27
SEPTODONT, INC.
HYDROL
1976-09-27
SEPTODONT, INC.
DETARTRINE P
1976-09-27
SEPTODONT, INC.
CALCIPULPE
1976-09-27
SEPTODONT, INC.

GUDID#

Synapse Dental Pain Eraser-Professional Use - Synapse Dental Pain Eraser-Professional Use and Replacement Tips
Septodont, Inc.
2026-09-04
Synapse Dental Pain Eraser-Home Use - Synapse Dental Pain Eraser-Take Home
Septodont, Inc.
2026-09-04