septodont.comSEPTODONT ETCH 4 X 4GM KIT - 01C2032
2016-09-12
Septodont, Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008242564 | 3008242564 | Septodont, Inc | 1 | Y | 2026-01-01 | 205 Granite Run Dr., Suite 150 Lancaster PA US 17601 |
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 |
| 00303620000949 | SEPTODONT IMAGE MH L/C REFILL SYRINGE BW - 01C2093 | (303) 665-7535 | usregulatoryaffairs@septodont.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 238145 | 1065341210 | K952930 | DENTRAY II PLUS TRAY ADHESIVE | ELW | 1995-09-08 |
| 238145 | 2065456278 | K870147 | CARERITE & COST RITE NYLON STERILIZATION FILM | FRG | 1987-04-23 |
| 238145 | 1065432153 | K193570 | Dental Pain Eraser | LWM | 2020-01-17 |
| 238145 | 1529286251 | K192429 | Dental Pain Eraser | LWM | 2020-01-14 |
| 238145 | 1571422964 | K092943 | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | EJI | 2009-12-11 |
| 238145 | 1378806154 | K051291 | NON-STERILE SURGICAL MASK | FXX | 2005-09-20 |
| 238145 | 1258714600 | K042614 | S&C-SELF ETCH PR-BOND | KLE | 2004-11-22 |
| 238145 | 1824999639 | K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | EJI | 2000-10-13 |
| 238145 | 1995269769 | ||||
| 238145 | 2011883422 | ||||
| 238145 | 1754269956 |
Product Codes Associated With Registrations#
GUDID#
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 IMAGE MH L/C REFILL SYRINGE BW - 01C2093
2016-09-12
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
ASPIJECT SELF ASPIRATING SYRINGE - Dental cartridge syringe
2016-09-15
ASPIJECT WITH O-RING - Dental cartridge syringe
2016-09-15
SEPTODONT PETITE - BLUE - Aspirating Syringe Small Blue Septodont USA
2016-09-12
SEPTODONT FUSION(TITANIUM) SYRINGE - Aspirating Syringe Medium Titanium Fusion Septodont USA
2016-09-12
SEPTODONT STANDARD- GOLD - Aspirating Syringe Large Gold Septodont USA
2016-09-12
SEPTODONT PINK PETITE ASPIRATING SYRINGE - Aspirating Syringe Small Pink Septodont USA
2016-09-12
SEPTODONT ECO-A ASPIRATING SYR WINGLESS - Aspirating Syringe Eco-A
2016-09-12
SEPTODONT ECO-CW ASPIRATING SYR WINGED - Aspirating Syringe Eco-CW
2016-09-12
EARLOOP FACE MASK BLUE 3 PLY (2115) - FACEMASK BLUE E/L
2016-09-12
EARLOOP FACE MASK PINK 3 PLY (2116) - FACEMASK PINK E/L
2016-09-12
EARLOOP FACE MASK WHITE 3 PLY (2130) - MASK E/L WH L1
2016-09-12
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
2 INCH CLEAR CONT NYL FILM (0002) - 01I0002
2016-09-12
3 INCH CLEAR CONT NYLON FILM (0003) - 01I0003
2016-09-12
4 INCH CLEAR CONT NYLON FILM (0004) - 01I0004
2016-09-12
6 INCH CLEAR CONT NYLON FILM (0006) - 01I0006
2016-09-12
2 INCH LOGO CONT NYLON FILM (0012) - 01I0012
2016-09-12
3 INCH LOGO CONT NYLON FILM (0013) - 01I0013
2016-09-12
4 INCH LOGO CONT NYLON FILM (0014) - 01I0014
2016-09-12
6 INCH LOGO CONT NYLON FILM (0016) - 01I0016
2016-09-12
2 INCH LOGO PERF NYLON FILM (0022) - 01I0022
2016-09-12
3 INCH LOGO PERF NYLON FILM (0023) - 01I0023
2016-09-12
4 INCH LOGO PERF NYLON FILM (0024) - 01I0024
2016-09-12
6 INCH LOGO PERF NYLON FILM (0026) - 01I0032
2016-09-12
2 INCH SELF SEAL POUCH (0032) - 01I0032
2016-09-12
3 INCH SELF SEAL POUCH (0033) - 01I0033
2016-09-12
4 INCH SELF SEAL POUCH (0034) - 01I0034
2016-09-12
6 INCH SELF SEAL POUCH (0036) - 01I0036
2016-09-12
PAROJECT - Dental cartridge syringe
2016-09-15
PLUNGER FOR PAROJECT-HF02500A1 - Spare part for dental cartridge syringe
2016-09-15
Novocol EXACTON HARD CHRSD RELINE PWD/LIQ - FP-NOVOINC-125
2016-09-12