FDA.reportPublic FDA data

COTISEN

Primary DI
06954454000434
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
DB07
Device description
Denture box is used to store denture, impression tray, retainer and so on to keep them clean and hygiene from dust.
Published
2026-10-28
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
ILSAdaptor, Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454000434PrimaryGS10
86954454000430Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454000434069544540004346954454000434
8695445400043086954454000430

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleaning containerA non-powered receptacle intended to be used to clean/rinse a denture or similar dental prosthesis (e.g., a bridge). It is in the form of a container intended to hold the denture, typically with a denture cleansing solution, which may be manually agitated. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
529444628
Device count
4
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
06954454000441COTISENDB062026-10-28
06954454000465COTISENCD012026-10-28
06954454000472COTISENCD022026-10-28
06954454000489COTISENCD032026-10-28
06954454000564COTISENBB012026-10-28
06954454000571COTISENBB022026-10-28
06954454000588COTISENBB032026-10-28
06954454000595COTISENBF012026-10-28
06954454000601COTISENBC012026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000373COTISENHuanghua Promisee Dental Co., Ltd.ILS2026-10-28
06954454000380COTISENHuanghua Promisee Dental Co., Ltd.ILS2026-10-28
06954454000397COTISENHuanghua Promisee Dental Co., Ltd.ILS2026-10-28
06954454000403COTISENHuanghua Promisee Dental Co., Ltd.ILS2026-10-28
06954454000410COTISENHuanghua Promisee Dental Co., Ltd.ILS2026-10-28
06954454000441COTISENHuanghua Promisee Dental Co., Ltd.ILS2026-10-28
00840117348684dmecare Solutions Folding Bedside Commode, With Collapsible BucketDynarex CorporationILS2026-10-23
00810226442788ViveVIVE HEALTH LLCILS2026-09-30
06972077025832CostcareXIAMEN ATLANTIS MFC CO.,LTDILS2026-09-24
06975084500620ArjoXIAMEN ATLANTIS MFC CO.,LTDILS2026-09-24
00818323020014ViveVIVE HEALTH LLCILS2026-07-16
00810226441002ViveVIVE HEALTH LLCILS2026-07-08
00023601023186CarexDrive Devilbiss HealthcareILS2026-04-29
14895262521362HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
14895262521829SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521048HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521390HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521574HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521727SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521304HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521670HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521779SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521578HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521677HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521721SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521776SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521544HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521551HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521159HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521166HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22