Device
Scan body for use with 1.20mm/0.048in hex dental implant connections during digital scanning procedures.
Manufacturer
DIGITAL ARCHES INC.
Model: 1.20mm/0.048in Hex Catalog: OS-SCNBDY120-01 DI: 00810222550371 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
Scan body for use with 1.20mm/0.048in hex dental implant connections during digital scanning procedures.
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 50ec2a23-a7f3-4d08-ad81-ddd68636aebd
Distribution Status: In Commercial Distribution
DUNS Number: 145248707
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
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: 00810222550371
Type: Primary
Issuing Agency: GS1
GMDN
Code: 44880
Name: Dental implant suprastructure, temporary, preformed, single-use
Definition:
A 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.
FDA Product Codes
NDP
Accessories, Implant, Dental, Endosseous