FDA.reportPublic FDA data

ARCHTRACER™

Primary DI
00810222550081
Brand
ARCHTRACER™
Company
DIGITAL ARCHES INC.
Model
28mm
Catalog number
AT-PLDR28MM
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
00810222550081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810222550081008102225500818102225500810810222550081

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
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
00840456224496JMUJMU DENTAL, INCDZA2026-07-29
00840456224502JMUJMU DENTAL, INCDZA2026-07-29
00840456224519JMUJMU DENTAL, INCDZA2026-07-29
00840456224526JMUJMU DENTAL, INCDZA2026-07-29
00840456224533JMUJMU DENTAL, INCDZA2026-07-29
00840456224540JMUJMU DENTAL, INCDZA2026-07-29
00840456224557JMUJMU DENTAL, INCDZA2026-07-29
00840456224564JMUJMU DENTAL, INCDZA2026-07-29
08806343926302Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926319Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926326Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926333Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926340Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926357Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926364Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926371Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08800070248706Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248713Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248720Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248737Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248744Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248751Short DrillIzenimplant Co., Ltd.DZA2026-07-27
07290116660677Surgical DrillsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-07-12
07290116154787Dental DrillsNORIS MEDICAL LTDDZA2026-07-09
07290116154794Diamond BurrsNORIS MEDICAL LTDDZA2026-07-09
088000702492151.2 Hex Angled Machine Screw DriverIzenimplant Co., Ltd.DZA2026-06-22
06932195393831DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393848DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393855DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393879DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10