FDA.reportPublic FDA data

COTISEN

Primary DI
06954454014387
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
Z1
Device description
It is mainly used to fix dental dam during dental treatment.
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
EJGForceps, Rubber Dam Clamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454014387PrimaryGS10
86954454014383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454014387069544540143876954454014387
8695445401438386954454014383

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
2
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
06954454003879COTISENRD092026-11-05
06954454003886COTISENRD112026-11-05
06954454003916COTISENRD052026-11-05
06954454003923COTISENRD062026-11-05
06954454004791COTISEN442026-11-05
06954454007037COTISENPC05M2026-11-05
06954454007112COTISENPC05F2026-11-05
06954454010730COTISENRD122026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454003886COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454003923COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454004791COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454010747COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454010754COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454010761COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454010778COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454010785COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454010792COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454010990COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454011003COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454011010COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454011027COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454011034COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454011041COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454011058COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454011065COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454011072COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454013595COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454014370COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454014561COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454014578COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
06954454014585COTISENHuanghua Promisee Dental Co., Ltd.EJG2026-11-05
G8791032710DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032720DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G149TBSB2110TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2120TBS BASICSACME ENTERPRISE.EJG2026-05-16