FDA.reportPublic FDA data

COTISEN

Primary DI
06954454015605
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
PB01E
Device description
It is used for polishing the tooth restoration, and also for cleaning and polishing the surface of the tooth to make the surface smooth and even.
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
EHKCup, Prophylaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454015605PrimaryGS10
86954454015601Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454015605069544540156056954454015605
8695445401560186954454015601

Contacts#

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

Regulatory Flags#

DUNS number
529444628
Device count
100
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
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
06954454002490COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454002506COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454002513COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454002520COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454002537COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454002544COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454002551COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454002568COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454002575COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015537COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015544COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015551COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015568COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015575COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015582COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015599COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015612COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015629COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015636COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015643COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015650COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015667COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454015674COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-11-05
06954454002582COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002599COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002605COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002612COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002629COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002636COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002643COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23