ARCHTRACER™ - Handheld driver for placement and removal of ARCHTRACER fiducial markers.
2026-04-30
DIGITAL ARCHES INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3035983708 | 3035983708 | DIGITAL ARCHES INC. | 1 | Y | 2026-01-01 | 17197 Newhope St Ste J Fountain Valley CA US 92708 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 340564 | 1589961686 | K243353 | One-Fil Putty | KIF | 2025-03-14 |
| 340564 | 1368023075 | K214003 | Dental Zirconia Pre-shaded Block | EIH | 2022-02-18 |
| 340564 | 1371011392 | ||||
| 340564 | 1606625294 |
Product Codes Associated With Registrations#
GUDID#
ARCHTRACER™ - Handheld driver for placement and removal of ARCHTRACER fiducial markers.
2026-04-30
ARCHTRACER™ - Pilot drill for preparation of the osseous site prior to placement of ARCHTRACER fiducial markers.
2026-04-30
ARCHTRACER™ - Pilot drill for preparation of the osseous site prior to placement of ARCHTRACER fiducial markers.
2026-04-30
OPTISPLINT® - Verification jig frame for use with OPTISPLINT scan bodies during digital scanning procedures.
2026-04-30
OPTISPLINT® - Verification jig frame for use with OPTISPLINT scan bodies during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan body for use with 1.20mm/0.048in hex dental implant connections during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan body for use with 1.27mm/0.050in hex dental implant connections during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan body for use with M1.6mm thread with hex dental implant connections during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan body for use with Nobel Biocare Unigrip dental implant connections during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan body for use with Neodent NEO dental implant connections during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan body for use with Straumann SCS dental implant connections during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan cap for use with analog implant models during laboratory digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan cap for use with 1.20mm/0.048in hex multi-unit abutments during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan cap for use with 1.27mm/0.050in hex multi-unit abutments during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan cap for use with Nobel Biocare Unigrip multi-unit abutments during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan cap for use with Neodent NEO multi-unit abutments during digital scanning procedures.
2026-04-30
OPTISPLINT® - Scan cap for use with Straumann SCS multi-unit abutments during digital scanning procedures.
2026-04-30
OPTIWELD™ - Reusable dual-component mixing gun used to dispense OPTIWELD dual-cure composite material from standard 5cc mixing cartridges during dental prosthetic procedures.
2026-04-29
PIXELSTONE™ - Pre-sintered 8-layer polychromatic zirconia milling blank, Shade A1, 20mm thickness, 98mm diameter. Multilayer construction with 3Y, 4Y, and 5Y zirconia providing a cervical-to-incisal strength range of 700-1200 MPa and translucency range of 43-57%. Intended for CAD/CAM milling of full-arch implant-supported zirconia prostheses followed by sintering per manufacturer specifications.
2026-04-29
PIXELSTONE™ - Pre-sintered 8-layer polychromatic zirconia milling blank, Shade A1, 25mm thickness, 98mm diameter. Multilayer construction with 3Y, 4Y, and 5Y zirconia providing a cervical-to-incisal strength range of 700-1200 MPa and translucency range of 43-57%. Intended for CAD/CAM milling of full-arch implant-supported zirconia prostheses followed by sintering per manufacturer specifications.
2026-04-29
PIXELSTONE™ - Pre-sintered 8-layer polychromatic zirconia milling blank, Shade A2, 20mm thickness, 98mm diameter. Multilayer construction with 3Y, 4Y, and 5Y zirconia providing a cervical-to-incisal strength range of 700-1200 MPa and translucency range of 43-57%. Intended for CAD/CAM milling of full-arch implant-supported zirconia prostheses followed by sintering per manufacturer specifications.
2026-04-29
PIXELSTONE™ - Pre-sintered 8-layer polychromatic zirconia milling blank, Shade A2, 25mm thickness, 98mm diameter. Multilayer construction with 3Y, 4Y, and 5Y zirconia providing a cervical-to-incisal strength range of 700-1200 MPa and translucency range of 43-57%. Intended for CAD/CAM milling of full-arch implant-supported zirconia prostheses followed by sintering per manufacturer specifications.
2026-04-29
PIXELSTONE™ - Pre-sintered 8-layer polychromatic zirconia milling blank, Shade B1, 20mm thickness, 98mm diameter. Multilayer construction with 3Y, 4Y, and 5Y zirconia providing a cervical-to-incisal strength range of 700-1200 MPa and translucency range of 43-57%. Intended for CAD/CAM milling of full-arch implant-supported zirconia prostheses followed by sintering per manufacturer specifications.
2026-04-29
PIXELSTONE™ - Pre-sintered 8-layer polychromatic zirconia milling blank, Shade B1, 25mm thickness, 98mm diameter. Multilayer construction with 3Y, 4Y, and 5Y zirconia providing a cervical-to-incisal strength range of 700-1200 MPa and translucency range of 43-57%. Intended for CAD/CAM milling of full-arch implant-supported zirconia prostheses followed by sintering per manufacturer specifications.
2026-04-29
PIXELSTONE™ - Pre-sintered 8-layer polychromatic zirconia milling blank, Shade OM3, 20mm thickness, 98mm diameter. Multilayer construction with 3Y, 4Y, and 5Y zirconia providing a cervical-to-incisal strength range of 700-1200 MPa and translucency range of 43-57%. Intended for CAD/CAM milling of full-arch implant-supported zirconia prostheses followed by sintering per manufacturer specifications.
2026-04-29
PIXELSTONE™ - Pre-sintered 8-layer polychromatic zirconia milling blank, Shade OM3, 25mm thickness, 98mm diameter. Multilayer construction with 3Y, 4Y, and 5Y zirconia providing a cervical-to-incisal strength range of 700-1200 MPa and translucency range of 43-57%. Intended for CAD/CAM milling of full-arch implant-supported zirconia prostheses followed by sintering per manufacturer specifications.
2026-04-29
OPTISPLINT® - Kit containing color-coded dental implant prosthetic drivers and torque wrench for placement and removal of implant-supported restorations. Includes drivers for common implant connection types: 1.0mm Hex, 1.16mm Hex, 1.20mm/0.048in Hex, 1.25mm Hex, 1.27mm/0.050in Hex, 1.40mm Hex, Torx T5, and Torx T6. Stored in anodized metal case.
2026-04-29