FDA.reportPublic FDA data

COTISEN

Primary DI
06954454002414
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
RD01
Device description
Dental Dam Kit is used to isolated teeth during dental treatment to prevent accidental swallowing or inhalation of small instruments or material debris in operation;Prevent soft tissue injury caused by rotating instruments or manual instruments.
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
false

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
06954454002414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454002414069544540024146954454002414

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
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
06954454003879COTISENRD092026-11-05
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
06954454002421COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454002438COTISENHuanghua Promisee Dental Co., Ltd.EEF2026-11-05
06954454003879COTISENHuanghua 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