FDA.reportPublic FDA data

COTISEN

Primary DI
06954454003879
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
RD09
Device description
Dental wedge is used to fix dental dam.
Published
2026-11-05
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
EEFClamp, Rubber Dam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEFClamp, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454003879PrimaryGS10
86954454003875Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454003879069544540038796954454003879
8695445400387586954454003875

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
20
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
06954454002414COTISENRD012026-11-05
06954454002421COTISENRD022026-11-05
06954454002438COTISENRD032026-11-05
06954454002490COTISENPB01A2026-11-05
06954454002506COTISENPB01B2026-11-05
06954454002513COTISENPB01C2026-11-05
06954454002520COTISENPB02A2026-11-05
06954454002537COTISENPB02B2026-11-05
06954454002544COTISENPB02C2026-11-05
06954454002551COTISENPB03A2026-11-05
06954454002568COTISENPB03B2026-11-05
06954454002575COTISENPB03C2026-11-05
06954454003886COTISENRD112026-11-05
06954454003916COTISENRD052026-11-05
06954454003923COTISENRD062026-11-05
06954454004791COTISEN442026-11-05
06954454007037COTISENPC05M2026-11-05
06954454007112COTISENPC05F2026-11-05
06954454010730COTISENRD122026-11-05
06954454010747COTISEN552026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454002414COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454002421COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454002438COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454010730COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454013441COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454013540COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454013724COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454014165COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454014752COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454016220COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
G879RDC000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC14A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC201B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC202B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2040DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2060DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC206B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2070DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC207B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22