Device
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-in...
Manufacturer
DIGITAL ARCHES INC.
DIGITAL ARCHES INC.
Model: OM3 / 20mm
Catalog: ZR-PXLSTOM3-20M
DI: 00810222551309
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9591591b-2c16-4749-8505-01c105f132b5
Distribution Status:
In Commercial Distribution
DUNS Number:
145248707
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810222551309
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16187
Name: Dental appliance fabrication material, ceramic
Definition:
A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
FDA Product Codes
EIH
Powder, Porcelain