FDA.report

SEPTODONT N-DURANCE TIP REF 20-0.25GA3.5

Primary DI
00303620001045
Brand
SEPTODONT N-DURANCE TIP REF 20-0.25GA3.5
Company
SEPTODONT, INC
Model
01C3014
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
true

Related Records

Contact Domains

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00303620001045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00303620001045003036200010453036200010450303620001045

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
Weight0.25Gram

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 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
false
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815967025856RodinPac-Dent, Inc.EBF2026-03-24
00815967025863RodinPac-Dent, Inc.EBF2026-03-24
00815967025870RodinPac-Dent, Inc.EBF2026-03-24
00815967021438OptiCompPac-Dent, Inc.EBF2026-03-23
00815967021797OptiCompPac-Dent, Inc.EBF2026-03-23
00815967027447RodinPac-Dent, Inc.EBF2026-03-23
00815967028161RodinPac-Dent, Inc.EBF2026-03-23
00815967028178RodinPac-Dent, Inc.EBF2026-03-23
00815967028185RodinPac-Dent, Inc.EBF2026-03-23
00815967028192RodinPac-Dent, Inc.EBF2026-03-23
00815967028208RodinPac-Dent, Inc.EBF2026-03-23
00815967028215RodinPac-Dent, Inc.EBF2026-03-23
00815967028222RodinPac-Dent, Inc.EBF2026-03-23
00815967028239RodinPac-Dent, Inc.EBF2026-03-23
00815967028246RodinPac-Dent, Inc.EBF2026-03-23
00815967028253RodinPac-Dent, Inc.EBF2026-03-23
00815967028260RodinPac-Dent, Inc.EBF2026-03-23
00815967028277RodinPac-Dent, Inc.EBF2026-03-23
00815967028284RodinPac-Dent, Inc.EBF2026-03-23
00815967028291RodinPac-Dent, Inc.EBF2026-03-23
00815967028307RodinPac-Dent, Inc.EBF2026-03-23
00815967028314RodinPac-Dent, Inc.EBF2026-03-23
00815967028321RodinPac-Dent, Inc.EBF2026-03-23
00815967028338RodinPac-Dent, Inc.EBF2026-03-23
00815967028345RodinPac-Dent, Inc.EBF2026-03-23
00815967028352RodinPac-Dent, Inc.EBF2026-03-23
00815967028369RodinPac-Dent, Inc.EBF2026-03-23
00815967028376RodinPac-Dent, Inc.EBF2026-03-23
00815967028383RodinPac-Dent, Inc.EBF2026-03-23
00815967028390RodinPac-Dent, Inc.EBF2026-03-23