Device
Scan cap for use with 1.27mm/0.050in hex multi-unit abutments during digital scanning procedures.
Manufacturer
DIGITAL ARCHES INC.
DIGITAL ARCHES INC.
Model: 1.27mm/0.050in Hex
Catalog: OS-SCNCAPMUA127-01
DI: 00810222550678
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 cap for use with 1.27mm/0.050in hex multi-unit abutments during digital scanning procedures.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1495934f-2129-4e87-bfcc-cf104dce8867
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:
00810222550678
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