Alliedstar Sensa 6583440

GUDID 06973993442512

Alliedstar Medical Equipment Co., Ltd.

Intraoral optical scanning system
Primary Device ID06973993442512
NIH Device Record Keye4b6a094-fc65-43e9-965e-03c50fb69c99
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlliedstar Sensa
Version Model NumberS300W
Catalog Number6583440
Company DUNS703541803
Company NameAlliedstar Medical Equipment Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973993442512 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06973993442512]

Moist Heat or Steam Sterilization


[06973993442512]

Moist Heat or Steam Sterilization


[06973993442512]

Moist Heat or Steam Sterilization


[06973993442512]

Moist Heat or Steam Sterilization


[06973993442512]

Moist Heat or Steam Sterilization


[06973993442512]

Moist Heat or Steam Sterilization


[06973993442512]

Moist Heat or Steam Sterilization


[06973993442512]

Moist Heat or Steam Sterilization


[06973993442512]

Moist Heat or Steam Sterilization


[06973993442512]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-16
Device Publish Date2025-06-06

On-Brand Devices [Alliedstar Sensa]

06973993442529S300W
06973993442512S300W
06973993442284S300W
06973993441676TP301
06973993441645CHR 300W
06973993440242S300W

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.