FDA.reportPublic FDA data

SEPTODONT USA SEPTOETCH 12-1.6GM SYR

Primary DI
00303620000635
Brand
SEPTODONT USA SEPTOETCH 12-1.6GM SYR
Company
SEPTODONT, INC
Model
01C2034
Catalog number
01C2034
Device description
SEPTODONT USA SEPTOETCH 12-1.6GM SYR
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00303620000635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00303620000635003036200006353036200006350303620000635

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1.5Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(303) 665-7535usregulatoryaffairs@septodont.com

Regulatory Flags#

DUNS number
012925513
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303620000628SEPTODONT ETCH 4 X 4GM KIT01C203201C20322016-09-12
00303620000642SEPTODONT ETCHANT 60GM SYR KIT01C203501C20352016-09-12
00303620000857SEPTODONT HZ IMAGE MH COMP L/C SYR KIT01C20802016-09-12
00303620000949SEPTODONT IMAGE MH L/C REFILL SYRINGE BW01C20932016-09-12
03760140703601R.T.R Membrane9625M2017-07-14
03760140703625R.T.R Membrane 9627O2017-07-14
03760140703618R.T.R Membrane 9626N2017-07-14
00303620000000ASPIJECT SELF ASPIRATING SYRINGE01N202001N20202016-09-15
00303620000017ASPIJECT WITH O-RING01N203001N20302016-09-15
00303620000048SEPTODONT PETITE - BLUE01N210001N21002016-09-12
00303620000055SEPTODONT FUSION(TITANIUM) SYRINGE01N21052016-09-12
00303620000062SEPTODONT STANDARD- GOLD01N211001N21102016-09-12
00303620000079SEPTODONT PINK PETITE ASPIRATING SYRINGE01N212001N21202016-09-12
00303620000086SEPTODONT ECO-A ASPIRATING SYR WINGLESS01N220001N22002016-09-12
00303620000093SEPTODONT ECO-CW ASPIRATING SYR WINGED01N221001N22102016-09-12
00303620000291EARLOOP FACE MASK BLUE 3 PLY (2115)01I21152016-09-12
00303620000307EARLOOP FACE MASK PINK 3 PLY (2116)01I21162016-09-12
00303620000314EARLOOP FACE MASK WHITE 3 PLY (2130)01I21302016-09-12
13760140703608R.T.R Membrane9625M2017-07-14
13760140703622R.T.R Membrane 9627O2017-07-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
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506058610362573M™ Adper™3M COMPANYKLE2026-04-17
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D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
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07615208296136Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
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