FDA.reportPublic FDA data

COTISEN

Primary DI
06954454003992
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
QI17A
Device description
Dental Bib is mainly used to fix it in front of the patient's chest during oral treatment, prevent splashes from causing infection on the patient's chest.
Published
2026-11-02
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
KHRAbsorber, Saliva, Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454003992PrimaryGS10
86954454003998Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454003992069544540039926954454003992
8695445400399886954454003998

Contacts#

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

Regulatory Flags#

DUNS number
529444628
Device count
125
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
06954454000755COTISENMM012026-11-03
06954454000762COTISENMM042026-11-03
06954454001493COTISENMP042026-11-03
06954454002162COTISENMP032026-11-03
06954454002179COTISENMP032026-11-03
06954454004807COTISENDB212026-11-03
06954454004852COTISENMP032026-11-03
06954454006931COTISENMM052026-11-03
06954454010129COTISENMM02A2026-11-03
06954454010136COTISENMM02B2026-11-03
06954454010143COTISENMM02C2026-11-04
06954454010150COTISENMM02D2026-11-04
06954454010167COTISENMM02E2026-11-04
06954454010174COTISENMM02F2026-11-04
06954454010181COTISENMM02G2026-11-04
06954454010198COTISENMM02H2026-11-04
06954454010204COTISENMM022026-11-03
06954454012291COTISENMM07A2026-11-03
06954454012802COTISENDB22A2026-11-03
06954454012826COTISENDB22B2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454014769COTISENHuanghua Promisee Dental Co., Ltd.KHR2026-11-02
06954454016190COTISENHuanghua Promisee Dental Co., Ltd.KHR2026-11-02
00840456225394JMUJMU DENTAL, INCKHR2026-10-13
00840456225165JMUJMU DENTAL, INCKHR2026-09-18
00840456201428JMUJMU DENTAL, INCKHR2026-07-08
00840456217696JMUJMU DENTAL, INCKHR2026-06-05
00840456222188JMUJMU DENTAL, INCKHR2026-06-05
00840456222195JMUJMU DENTAL, INCKHR2026-06-05
00840456223000JMUJMU DENTAL, INCKHR2026-06-05
00840456223017JMUJMU DENTAL, INCKHR2026-06-05
00840456201756JMUJMU DENTAL, INCKHR2026-05-27
00840456201763JMUJMU DENTAL, INCKHR2026-05-27
00840456201770JMUJMU DENTAL, INCKHR2026-05-27
00840456201787JMUJMU DENTAL, INCKHR2026-05-27
00840456201794JMUJMU DENTAL, INCKHR2026-05-27
00840456221020JMUJMU DENTAL, INCKHR2026-05-27
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10371347011460Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011477Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011484Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011491Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011507Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
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