Device
Kit containing color-coded dental implant prosthetic drivers and torque wrench for placement and removal of implant-supported restorations. Includes drivers for common implant conn...
Manufacturer
DIGITAL ARCHES INC.
DIGITAL ARCHES INC.
Model: N/A
Catalog: IN-UPROSKIT
DI: 00810222551323
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
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.
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:
4b06a2e4-c10c-439f-9848-4bfb4dbf34d1
Distribution Status:
In Commercial Distribution
DUNS Number:
145248707
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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:
00810222551323
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45147
Name: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Definition:
A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.
FDA Product Codes
None