FDA.reportPublic FDA data

COXO

Primary DI
06974267891203
Brand
COXO
Company
Foshan COXO Medical Instrument Co.,Ltd.
Model
C-FILL MINI
Device description
Endodontic Obturation Systems
Published
2024-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974267891203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974267891203069742678912036974267891203

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation systemAn assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529860171
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974267890107COXOCX207-G2024-12-18
06974267890558COXODB686 NANO2024-12-18
06974267890572COXOC-FILL2024-12-18
06974267890640COXOCX249-212024-12-18
06974267890657COXOCX249-222024-12-18
06974267890671COXOCX249-242024-12-18
06974267890688COXODB3382024-12-18
06974267890718COXOC-BLADE2024-12-18
06974267890886COXOCX207-G2024-12-18
06974267891104COXOC-Sailor Pro2024-07-04
06974267890374COXOC-Smart-I Pro2024-11-05
06974267890442COXOC-ROOT I2024-07-04
06974267890565COXODB686 Swift2024-07-04
06974267890664COXOCX249-232024-07-04
06974267891074COXOC-SMART-I PILOT2024-07-04
06974267891197COXOC-FILL MINI2024-07-04
06974267891982COXOCX207-22024-07-04
06974267890039COXOCX207-A2024-03-30
06974267890138COXOCX235-1B2024-03-30
06974267890152COXO CX235-1F2024-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001615COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002681COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002698COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004227COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004234COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004241COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004258COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004265COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004272COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004289COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004296COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004302COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004319COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006382COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006399COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006405COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454012024COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014523COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014530COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014547COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015230COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015360COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015377COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015384COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015391COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015407COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015414COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015421COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015438COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015445COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27