FDA.reportPublic FDA data

COTISEN

Primary DI
06954454001608
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
SC0501L
Device description
The matrix bands are used to act as a barrier or aids in the shaping of the restorations.
Published
2026-10-26
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
06954454001608PrimaryGS10
86954454001604Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454001608069544540016086954454001608
8695445400160486954454001604

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
06954454000045COTISENBA012026-10-26
06954454000267COTISENAT01L2026-10-26
06954454000366COTISENDD012026-10-26
06954454000748COTISENBH012026-10-26
06954454001301COTISENDD022026-10-26
06954454001318COTISENMW022026-10-26
06954454001325COTISENMW012026-10-26
06954454001349COTISENDD030A2026-10-26
06954454001356COTISENDD030B2026-10-26
06954454001530COTISENSC02062026-10-26
06954454001547COTISENSC02052026-10-26
06954454001554COTISENSC02042026-10-26
06954454001622COTISENSC02012026-10-26
06954454001639COTISENSC02022026-10-26
06954454001646COTISENSC02032026-10-26
06954454001660COTISENSC0601L2026-10-26
06954454001677COTISENSC07012026-10-26
06954454002216COTISENSC092026-10-26
06954454002667COTISENSC0502M2026-10-26
06954454002674COTISENSC0503S2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001530COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001547COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001554COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001622COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001639COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001646COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001660COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001677COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002216COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002667COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002674COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454004203COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454004210COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454007310COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010815COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010822COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010839COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010846COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454011584COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454011744COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012086COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012949COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012956COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454013137COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454014516COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015896COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015902COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015919COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015926COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015933COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26