FDA.reportPublic FDA data

COXO

Primary DI
06974267891104
Brand
COXO
Company
Foshan COXO Medical Instrument Co.,Ltd.
Model
C-Sailor Pro
Device description
Dental Implantation Systems
Published
2024-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBWController, Foot, Handpiece And Cord
EGSHandpiece, Contra- And Right-Angle Attachment, Dental
KMWHandpiece, Rotary Bone Cutting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1
KMWHandpiece, Rotary Bone CuttingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220831000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220831000Dental Implantation Systems, Dental Electrical MotorsFoshan Coxo Medical Instrument Co., Ltd.2022-09-27EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974267891104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974267891104069742678911046974267891104

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529860171
Device count
1
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
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
06974267891203COXOC-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
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10194665008444A-decA-DEC, INC.EBW2026-02-19
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHEBW2025-12-18
J021101008011S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008021S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008031S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
J021300320021WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11