Device
The Orion Kit is intended for intraoral scanning to capture precise positional information of dental implants or abutments. The device supports digital workflows for CAD/CAM system...
Manufacturer
Changzhou Sifary Medical Technology Co., Ltd.
Changzhou Sifary Medical Technology Co., Ltd.
Model: Orion Kit-M1.6
Catalog: 7680164
DI: 06941877829735
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
The Orion Kit is intended for intraoral scanning to capture precise positional information of dental implants or abutments. The device supports digital workflows for CAD/CAM systems, enabling the design and manufacture of dental prostheses.
The Orion Kit must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel.
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:
afed9637-c6ff-4894-a40a-a92310de60c2
Distribution Status:
In Commercial Distribution
DUNS Number:
560366787
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06941877829735
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61640
Name: Dental implant abutment analog, laboratory
Definition:
A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.
FDA Product Codes
NDP
Accessories, Implant, Dental, Endosseous