FDA.reportPublic FDA data

COTISEN

Primary DI
06954454000618
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
GD01
Device description
Mixing Bowl is mainly used for storing or mixing different dental material and medicine.
Published
2026-10-24
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
KYWContainer, Liquid Medication, Graduated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYWContainer, Liquid Medication, GraduatedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454000618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454000618069544540006186954454000618

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing surface, chairside, reusableA slab, tray, or well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic or glass and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). 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
06954454000533COTISENSP012026-10-24
06954454000540COTISENSP022026-10-24
06954454000557COTISENSP032026-10-24
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
06954454002636COTISENPC03B2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454014837COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454015162COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454015179COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454015186COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454015193COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454000656COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000663COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000670COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000687COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000694COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000700COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000717COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000724COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454001288COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454001295COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454015889COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
00724995252823V. MuellerSteris CorporationKYW2026-08-21
00724995252830V. MuellerSteris CorporationKYW2026-08-21
00724995252847V. MuellerSteris CorporationKYW2026-08-21
00724995252892V. MuellerSteris CorporationKYW2026-08-21
00724995252908V. MuellerSteris CorporationKYW2026-08-21
00724995252915V. MuellerSteris CorporationKYW2026-08-21
00724995252922V. MuellerSteris CorporationKYW2026-08-21
00840117346253Pill Crusher Pouches with Round CornersDynarex CorporationKYW2026-07-31
00840319759035Hayden MedicalHayden Medical, Inc.KYW2026-06-10
00827989007901Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007918Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
16931918145068AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2025-06-20
00661392002180LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00661392012332LSL HEALTHCARELSL Industries, LLCKYW2025-05-16