FDA.report

SEPTO N'D DIMER CORE BU WHITE 2X9G W/TPS

Primary DI
00303620001427
Brand
SEPTO N'D DIMER CORE BU WHITE 2X9G W/TPS
Company
SEPTODONT, INC
Model
8581C
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00303620001427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00303620001427003036200014273036200014270303620001427

GMDN Terms

TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Weight9Gram

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius24 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
(303) 665-7535usregulatoryaffairs@septodont.com

Regulatory Flags

DUNS number
012925513
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
13760140703608R.T.R Membrane9625M2017-07-14
03760140703618R.T.R Membrane 9626N2017-07-14
13760140703622R.T.R Membrane 9627O2017-07-14
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
003036200001092 INCH CLEAR CONT NYL FILM (0002)01I00022016-09-12
003036200001163 INCH CLEAR CONT NYLON FILM (0003)01I00032016-09-12
003036200001234 INCH CLEAR CONT NYLON FILM (0004)01I000401I00042016-09-12
003036200001306 INCH CLEAR CONT NYLON FILM (0006)01I00062016-09-12
003036200001472 INCH LOGO CONT NYLON FILM (0012)01I001201I00122016-09-12
003036200001543 INCH LOGO CONT NYLON FILM (0013)01I001301I00132016-09-12
003036200001614 INCH LOGO CONT NYLON FILM (0014)01I00142016-09-12
003036200001786 INCH LOGO CONT NYLON FILM (0016)01I001601I00162016-09-12
003036200001852 INCH LOGO PERF NYLON FILM (0022)01I002201I00222016-09-12
003036200001923 INCH LOGO PERF NYLON FILM (0023)01I00232016-09-12
003036200002084 INCH LOGO PERF NYLON FILM (0024)01I002401I00242016-09-12
003036200002156 INCH LOGO PERF NYLON FILM (0026)01I003201I00322016-09-12
003036200002222 INCH SELF SEAL POUCH (0032)01I003201I00322016-09-12
003036200002393 INCH SELF SEAL POUCH (0033)01I00332016-09-12

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