FDA.reportPublic FDA data

COTISEN

Primary DI
06954454004777
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
AT01
Device description
It’s a tool for applying drugs during dental treatment.
Published
2026-10-23
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
KXRApplicator, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454004777PrimaryGS10
86954454004773Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454004777069544540047776954454004777
8695445400477386954454004773

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
529444628
Device count
50
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
06954454000533COTISENSP012026-10-24
06954454000540COTISENSP022026-10-24
06954454000557COTISENSP032026-10-24
06954454000618COTISENGD012026-10-24
06954454000656COTISENSB01XL2026-10-23
06954454000663COTISENSB01L2026-10-23
06954454000670COTISENSB01M2026-10-23
06954454000687COTISENSB01S2026-10-23
06954454000694COTISENSB01SS2026-10-23
06954454000700COTISENMB012026-10-23
06954454000717COTISENMB022026-10-23
06954454000724COTISENMB032026-10-23
06954454001288COTISENMB042026-10-23
06954454001295COTISENMW032026-10-23
06954454001332COTISENMR012026-10-24
06954454002582COTISENPC01A2026-10-23
06954454002599COTISENPC01B2026-10-23
06954454002605COTISENPC02A2026-10-23
06954454002612COTISENPC02B2026-10-23
06954454002629COTISENPC03A2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454010921COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-23
06954454012307COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-23
06954454012314COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-23
00810194403293AiraAIRA, LLCKXR2026-08-25
00810194403309AiraAIRA, LLCKXR2026-08-25
00810194403323AiraAIRA, LLCKXR2026-08-25
00810194403330AiraAIRA, LLCKXR2026-08-25
00840456202555JMUJMU DENTAL, INCKXR2026-07-27
00840456202562JMUJMU DENTAL, INCKXR2026-07-27
00840456202579JMUJMU DENTAL, INCKXR2026-07-27
00840456202586JMUJMU DENTAL, INCKXR2026-07-27
00840456202593JMUJMU DENTAL, INCKXR2026-07-27
00840456218006JMUJMU DENTAL, INCKXR2026-07-27
00840456218013JMUJMU DENTAL, INCKXR2026-07-27
00840456218020JMUJMU DENTAL, INCKXR2026-07-27
00840456218037JMUJMU DENTAL, INCKXR2026-07-27
00840456202401JMUJMU DENTAL, INCKXR2026-07-08
00840456223222JMUJMU DENTAL, INCKXR2026-07-08
00840456223239JMUJMU DENTAL, INCKXR2026-07-08
D1257500B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502T4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502W4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21