RAYiOS2

GUDID 08800160000030

DDS INC

Intraoral optical scanning system
Primary Device ID08800160000030
NIH Device Record Key82f1ecbd-1f0e-47ad-94ad-839a1f8df84b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAYiOS2
Version Model NumberCOMFORT+
Company DUNS688424199
Company NameDDS INC
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
GS108800160000030 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-22
Device Publish Date2023-08-14

Devices Manufactured by DDS INC

08800160000030 - RAYiOS22023-08-22
08800160000030 - RAYiOS22023-08-22
08800160000016 - COMFORT+2022-05-27
08800160000023 - RAYiOS2022-05-27
18800160000006 - COMFORT+2021-11-05

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