DentalMark

Primary DI
B971VF101
Brand
DentalMark
Company
Jessop Precision Products Inc.
Model
DentalMark 1.0mm Visionline ball for Cone Beam CT
Published
2021-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JACSystem, X-Ray, Film Marking, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JACSystem, X-Ray, Film Marking, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B971VF101PrimaryHIBCC0
B971VF100Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental guided surgery registration/navigation spatial markerA non-powered device designed to be attached to the patient’s tooth/teeth to mark the location where a dental procedure (e.g., drilling, implant placement) is to occur during guided dental implantation surgery. It is intended to remain in situ during the preoperative patient registration chairside cone beam computerized tomography (CBCT) scan, and during the dental procedure, to assist with intraoperative navigation (e.g., using optical tracking). Also referred as a navigation fiducial marker, it is made of plastic and radiopaque materials and is attached via dental impression. This is a single-patient device which may be reattached to the patient during the procedure before being discarded.

Contacts#

Phone, Email table
PhoneEmail
800-406-3399orders@suremark.com

Regulatory Flags#

DUNS number
055127831
Device count
110
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B971RTC120SuremarkRadTatRTC-122024-02-01
B971RTD12L0SuremarkRadTatRTD-12L2024-02-01
B971RTD12S0SuremarkRadTatRTD-12S2024-02-01
B971RTC121SuremarkRadTatRTC-122024-02-01
B971RTD12L1SuremarkRadTatRTD-12L2024-02-01
B971RTD12S1SuremarkRadTatRTD-12S2024-02-01
B971CF231DentalMark2.3mm CT ball on denture sized label2021-10-08
B971DM11ScaneezScaneez DentureMark Upper Central2021-10-08
B971DM21ScaneezScaneez DentureMark Upper Lateral2021-10-08
B971DM31ScaneezScaneez DentureMark Upper Cuspid2021-10-08
B971DM41ScaneezScaneez DentureMark Universal Bicuspid 2021-10-08
B971DM51ScaneezScaneez DentureMark Universal Molar2021-10-08
B971DM61ScaneezScaneez DentureMark Lower Cuspid2021-10-08
B971DM71ScaneezScaneez DentureMark Lower Incisor2021-10-08
B971DM81DentalMarkDentalMark 2.0mm flat fiducial markers2021-10-08
B971VF201DentalMarkDentalMark 2.0mm Visionline ball on denture sized 2021-10-08
B971RTC1000SuremarkRadTatRTC-1002023-01-16
B971RTL100SuremarkRadTatRTL-102023-01-16
B971BL151BeautyLine1.5mm lead ball on BeautyLine Butterfly label2021-10-08
B971BL201BeautyLine2.0mm lead ball on BeautyLine Butterfly label2021-10-08

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B971RTC120SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12L0SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12S0SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTC121SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12L1SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12S1SuremarkJessop Precision Products Inc.JAC2024-02-01
03701313007942K-BALLS.M.A.I.OJAC2023-12-22
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B971RTC1000SuremarkJessop Precision Products Inc.JAC2023-01-16
B971RTL100SuremarkJessop Precision Products Inc.JAC2023-01-16
00815137022166R-SPOTBeekley CorporationJAC2023-01-09
00815137022173L-SPOTBeekley CorporationJAC2023-01-09
10815137022163R-SPOTBeekley CorporationJAC2023-01-09
10815137022170L-SPOTBeekley CorporationJAC2023-01-09
B201CGVM20Clear Guide VisiMARKER IICLEAR GUIDE MEDICAL, INC.JAC2022-10-04
B201CGVM2NS0Clear Guide VisiMARKER II Non-SterileCLEAR GUIDE MEDICAL, INC.JAC2022-10-04