FDA.reportPublic FDA data

Novocol EXACTON HARD CHRSD RELINE PWD/LIQ

Primary DI
07540187001450
Brand
Novocol EXACTON HARD CHRSD RELINE PWD/LIQ
Company
SEPTODONT, INC
Model
FP-NOVOINC-125
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
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540187001450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540187001450075401870014507540187001450

GMDN Terms#

Term, Definition table
TermDefinition
Denture reliner, elastic, short-termA denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
012925513
Device count
1
Premarket exempt
true
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
00303620000635SEPTODONT USA SEPTOETCH 12-1.6GM SYR01C203401C20342016-09-12
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

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