FDA.reportPublic FDA data

COTISEN

Primary DI
06954454013465
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
30G- B25
Device description
This product is used to irrigate the operation area during dental treatment, for cleaning, removing residues, and assisting in dental treatment.
Published
2026-10-27
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
ECBUnit, Syringe, Air And/Or Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454013465PrimaryGS10
86954454013461Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454013465069544540134656954454013465
8695445401346186954454013461

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material syringe, single-useA non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device.

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
06954454000069COTISENHP022026-10-28
06954454000076COTISENHP032026-10-28
06954454000083COTISENHP042026-10-28
06954454000090COTISENHP052026-10-28
06954454000106COTISENHP062026-10-28
06954454000113COTISENHP072026-10-28
06954454000373COTISENDB012026-10-28
06954454000380COTISENDB022026-10-28
06954454000397COTISENDB032026-10-28
06954454000403COTISENDB042026-10-28
06954454000410COTISENDB052026-10-28
06954454000434COTISENDB072026-10-28
06954454000441COTISENDB062026-10-28
06954454000465COTISENCD012026-10-28
06954454000472COTISENCD022026-10-28
06954454000489COTISENCD032026-10-28
06954454000564COTISENBB012026-10-28
06954454000571COTISENBB022026-10-28
06954454000588COTISENBB032026-10-28
06954454000595COTISENBF012026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001875COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454013472COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454013571COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454013908COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454013915COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454014363COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454014707COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454014714COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454014745COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454016060COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454016077COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454016084COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454016091COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
00810194402845AiraAIRA, LLCECB2026-08-26
00810194402852AiraAIRA, LLCECB2026-08-26
00810194402876AiraAIRA, LLCECB2026-08-26
00810194402883AiraAIRA, LLCECB2026-08-26
00810194402890AiraAIRA, LLCECB2026-08-26
00840456224465JMUJMU DENTAL, INCECB2026-07-24
00810230800116DCI PartsDCI International, LLCECB2026-06-26
00810230800123DCI PartsDCI International, LLCECB2026-06-26
00810230800130DCI PartsDCI International, LLCECB2026-06-26
00810230800147DCI PartsDCI International, LLCECB2026-06-26
00810230800154DCI PartsDCI International, LLCECB2026-06-26
00810230800161DCI PartsDCI International, LLCECB2026-06-26
00810230800178DCI PartsDCI International, LLCECB2026-06-26
00810230800185DCI PartsDCI International, LLCECB2026-06-26
00810230800192DCI PartsDCI International, LLCECB2026-06-26
00810230800208DCI PartsDCI International, LLCECB2026-06-26
00810230800215DCI PartsDCI International, LLCECB2026-06-26