FDA.reportPublic FDA data

COTISEN

Primary DI
06954454004593
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
SC1002
Device description
Dental sectional contoured matrices kits are used to reshape the adjacent relationships during composite restoration.
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
06954454004593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454004593069544540045936954454004593

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band kitA collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.

Contacts#

Phone, Email table
PhoneEmail
+1443-221-3031usa@medpath.pro

Regulatory Flags#

DUNS number
529444628
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06954454006757COTISENMJD02012026-10-22
06954454006764COTISENMJD02022026-10-22
06954454006771COTISENMJD02032026-10-22
06954454006788COTISENMJD02042026-10-22
06954454006795COTISENMJD02052026-10-22
06954454006801COTISENMJD02062026-10-22
06954454006818COTISENMJD02072026-10-22
06954454006825COTISENMJD02082026-10-22
06954454006832COTISENMJD02092026-10-22
06954454011737COTISENSC18042026-10-22
06954454012093COTISENSC1901A2026-10-22
06954454012109COTISENSC1902A2026-10-22
06954454012116COTISENSC1903A2026-10-22
06954454012123COTISENSC1901B2026-10-22
06954454012130COTISENSC1902B2026-10-22
06954454012147COTISENSC1903B2026-10-22
06954454013991COTISENMJD02112026-10-22
06954454014004COTISENMJD02122026-10-22
06954454014011COTISENMJD02132026-10-22
06954454014028COTISENMJD02142026-10-22

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
06954454004609COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004616COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004623COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21