FDA.reportPublic FDA data

ARCHTRACER™

Primary DI
00810222550050
Brand
ARCHTRACER™
Company
DIGITAL ARCHES INC.
Model
33mm
Catalog number
AT-DRVR33MM
Device description
Handheld driver for placement and removal of ARCHTRACER fiducial markers.
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810222550050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810222550050008102225500508102225500500810222550050

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant holding endpiece, reusableA device intended to hold a dental implant (e.g., orthodontic implant screw) at its distal end during the application of the implant to the patient’s oral cavity. It is typically a small metal shaft with an opening at its distal end designed to be mounted onto the distal end of a manual screwdriver or power tool whereby rotation is applied to introduce the implant into a surgical cavity. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
145248707
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810222550043ARCHTRACER™23mm2026-04-30
00810222550081ARCHTRACER™28mmAT-PLDR28MM2026-04-30
00810222550098ARCHTRACER™38mmAT-PLDR38MM2026-04-30
00810222550302OPTISPLINT®LargeOS-FRAMELG-012026-04-30
00810222550333OPTISPLINT®SmallOS-FRAMESM-012026-04-30
00810222550371OPTISPLINT®1.20mm/0.048in HexOS-SCNBDY120-012026-04-30
00810222550418OPTISPLINT®1.27mm/0.050 HexOS-SCNBDY127-012026-04-30
00810222550456OPTISPLINT®M1.6 thread w/HexOS-SCNBDYM16-012026-04-30
00810222550494OPTISPLINT®Nobel Biocare UnigripOS-SCNBDYNBL-012026-04-30
00810222550531OPTISPLINT®Neodent NEOOS-SCNBDYNEO-012026-04-30
00810222550579OPTISPLINT®Strauman SCSOS-SCNBDYSTM-012026-04-30
00810222550616OPTISPLINT®Pack of 6OS-SCNCAPANA-012026-04-30
00810222550647OPTISPLINT®1.20mm/0.048in HexOS-SCNCAPMUA120-012026-04-30
00810222550678OPTISPLINT®1.27mm/0.050in HexOS-SCNCAPMUA127-012026-04-30
00810222550708OPTISPLINT®Nobel Biocare UnigripOS-SCNCAPMUANBL-012026-04-30
00810222550739OPTISPLINT®Neodent NEOOS-SCNCAPMUANEO-012026-04-30
00810222550760OPTISPLINT®Straumann SCSOS-SCNCAPMUASTR-012026-04-30
00810222551156OPTIWELD™N/AOS-WELDER5CC2026-04-29
00810222551248PIXELSTONE™A1 / 20mmZR-PXLSTA1-20M2026-04-29
00810222551255PIXELSTONE™A1 / 25mmZR-PXLSTA1-25M2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800016100686Dental Implants Accesseories-Single UseCowellmedi Co.,LtdNDP2026-08-03
08800016108774Dental Implants Accesseories-ReusableCowellmedi Co.,LtdNDP2026-07-28
08800076476271T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-27
D7702682153RIGHT ANGLE SCREWDRIVER FORSWEDEN & MARTINA SPANDP2026-07-27
D7702698973DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702698983DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702750843INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
D7702750853INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
03701045246374KONTACTBIOTECH DENTALNDP2026-07-24
03701045246381KontactBIOTECH DENTALNDP2026-07-24
08800076470569HS Cap SmallTruabutment Korea Co.,LtdNDP2026-07-21
08800076475830T-L Digital AnalogTruabutment Korea Co.,LtdNDP2026-07-21
08800076476042T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-21
08800076476059T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476066T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476073T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476080T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476097T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476103T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476110T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476127T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476134T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476141T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476172T-Marker ScrewTruabutment Korea Co.,LtdNDP2026-07-21
08800076476219TruBite ScopeTruabutment Korea Co.,LtdNDP2026-07-21
08800076476226TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08800076476233TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08435673515131DYNAMIC ABUTMENT SOLUTIONSTALLADIUM ESPAÑA SLNDP2026-07-20
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14