FDA.reportPublic FDA data

COTISEN

Primary DI
06954454015360
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
SC2101L
Device description
The matrix bands are used to act as a barrier or aids in the shaping of the restorations.
Published
2026-10-27
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454015360PrimaryGS10
86954454015366Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454015360069544540153606954454015360
8695445401536686954454015366

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
529444628
Device count
50
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06954454000069COTISENHP022026-10-28
06954454000076COTISENHP032026-10-28
06954454000083COTISENHP042026-10-28
06954454000090COTISENHP052026-10-28
06954454000106COTISENHP062026-10-28
06954454000113COTISENHP072026-10-28
06954454000373COTISENDB012026-10-28
06954454000380COTISENDB022026-10-28
06954454000397COTISENDB032026-10-28
06954454000403COTISENDB042026-10-28
06954454000410COTISENDB052026-10-28
06954454000434COTISENDB072026-10-28
06954454000441COTISENDB062026-10-28
06954454000465COTISENCD012026-10-28
06954454000472COTISENCD022026-10-28
06954454000489COTISENCD032026-10-28
06954454000564COTISENBB012026-10-28
06954454000571COTISENBB022026-10-28
06954454000588COTISENBB032026-10-28
06954454000595COTISENBF012026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001615COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002681COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002698COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004227COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004234COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004241COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004258COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004265COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004272COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004289COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004296COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004302COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004319COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006382COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006399COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006405COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454012024COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014523COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014530COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014547COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015230COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015377COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015384COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015391COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015407COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015414COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015421COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015438COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015445COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015452COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27