FDA.reportPublic FDA data

OPTISPLINT®

Primary DI
00810222550531
Brand
OPTISPLINT®
Company
DIGITAL ARCHES INC.
Model
Neodent NEO
Catalog number
OS-SCNBDYNEO-01
Device description
Scan body for use with Neodent NEO dental implant connections during digital scanning procedures.
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00810222550531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810222550531008102225505318102225505310810222550531

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use 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
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
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
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14