FDA.reportPublic FDA data

SeptoMatrix Sectional Refill: 50 assorted matrices

Primary DI
07897990328459
Brand
SeptoMatrix Sectional Refill: 50 assorted matrices
Company
SEPTODONT SAS SPECIALITES SEPTODONT
Model
01C4014
Catalog number
01C4014
Device description
Preformed sectional matrices systems for Class II restorations.
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EKFInstrument, Contouring, Matrix, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKFInstrument, Contouring, Matrix, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07897990328459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07897990328459078979903284597897990328459

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
275273795
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303620001434Septodont Multi-Use Dispenser01C20562025-05-29
14719871634322Biodentine Mixer01C072501C07252025-04-25
03760140703359RACEGEL01C050001C05002016-09-12
03760140703243CIMPAT PINK01E011001E01102016-09-12
03760140703250CIMPAT WHITE01E012001E01202016-09-12
07897990328435SeptoWedges Refill: 100 Asst. wooden wedges01C402001C40202022-12-19
07897990328466SeptoMatrix Sectional Refill: 50 large matrices01C401501C40152022-12-16
07897990328473SeptoMatrix Sectional Refill: 50 medium matrices01C401601C40162022-12-16
07897990328480SeptoMatrix Sectional Refill: 50 small matrices01C401701C40172022-12-16
07897990328718SeptoPlus Mandrel Refill: 1 mandrel snap01C403101C40312022-12-19
07897990328725SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on01C400101C40012022-12-16
07897990328732SeptoDiscs Refill:1/2” 50 assorted abrasive discs01C400201C40022022-12-16
07897990328749SeptoDiscs Refill:1/2” 50 coarse abrasive discs01C400301C40032022-12-16
07897990328756SeptoDiscs Refill:1/2” 50 medium abrasive discs01C400401C40042022-12-16
07897990328763SeptoDiscs Refill: 1/2” - 50 fine abrasive discs01C400501C40052022-12-16
07897990328770SeptoDiscs Refill: 1/2” - 50 extra fine abrasive discs01C400601C40062022-12-16
07897990329081SeptoWedges Refill: 100 wooden wedges n°1-yellow01C402101C40212022-12-19
07897990329098SeptoWedges Refill: 100 wooden wedges n°2-blue01C402201C40222022-12-19
07897990329104SeptoWedges Refill: 100 wooden wedges n°3-red01C402301C40232022-12-19
07897990329111SeptoWedges Refill: 100 wooden wedges n°4-violet01C402401C40242022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454011737COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012093COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012109COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012116COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012123COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012130COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012147COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014493COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014509COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014653COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014660COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014677COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014684COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014691COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015223COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015490COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015506COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015827COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015834COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454000731COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454002049COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454003244COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454003251COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454003985COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004562COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004579COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004586COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004593COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004609COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004616COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21