FDA.reportPublic FDA data

COTISEN

Primary DI
06954454000243
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
CG01
Device description
It is used to deliver resin material into the patient's tooth cavity when repairing teeth.
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454000243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454000243069544540002436954454000243

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal medication dispenserA hand-held manual dental instrument intended to deliver medication (e.g., an antibiotic) directly into a periodontal pocket for the treatment of chronic periodontitis. It is typically a syringe-like device that has a ring-handled plunger, a barrel with finger grips, and a mechanism for holding an insertable cartridge containing the medication. It is usually made of high-grade stainless steel. This is a reusable device.

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
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
true

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
06954454001851COTISENHuanghua Promisee Dental Co., Ltd.KYX2026-10-27
06954454001868COTISENHuanghua Promisee Dental Co., Ltd.KYX2026-10-27
30813360023654UnoDoseCordica Medical, Inc.KYX2026-10-22
40813360023651UnoDoseCordica Medical, Inc.KYX2026-10-22
10813360023643UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023674UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023681UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023640UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023657UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023671UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023688UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023647UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023678UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023685UnoDoseCordica Medical, Inc.KYX2026-10-20
40813360023644UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023667UnoDoseCordica Medical, Inc.KYX2026-10-06
20813360023664UnoDoseCordica Medical, Inc.KYX2026-10-06
30813360023661UnoDoseCordica Medical, Inc.KYX2026-10-06
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22