FDA.reportPublic FDA data

ARCHTRACER™

Primary DI
00810222550098
Brand
ARCHTRACER™
Company
DIGITAL ARCHES INC.
Model
38mm
Catalog number
AT-PLDR38MM
Device description
Pilot drill for preparation of the osseous site prior to placement 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
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810222550098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810222550098008102225500988102225500980810222550098

GMDN Terms#

Term, Definition table
TermDefinition
Pin/post dental drill bitA shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. 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
00810222550050ARCHTRACER™33mmAT-DRVR33MM2026-04-30
00810222550081ARCHTRACER™28mmAT-PLDR28MM2026-04-30
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
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00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
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08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
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