IS 3600 I/O 3D Scanner 6568745

GUDID 00693856000005

Dental Imaging Technologies Corporation

Intraoral optical scanning system
Primary Device ID00693856000005
NIH Device Record Key96905da4-17cb-4fc0-9b60-d1a64768efef
Commercial Distribution StatusIn Commercial Distribution
Brand NameIS 3600 I/O 3D Scanner
Version Model Number6568745
Catalog Number6568745
Company DUNS800111106
Company NameDental Imaging Technologies Corporation
Device Count1
DM Exempttrue
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 Datefalse
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
GS100693856000005 [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 Date2022-09-14
Device Publish Date2022-09-06

Devices Manufactured by Dental Imaging Technologies Corporation

D090101289030 - DEXcam4 HD2025-12-19
00693856000159 - Assembly-IS 3600 SIDE TIP2025-12-12
00693856000173 - Assembly-IS 3600 POSTERIOR TIP2025-12-12
00693856000197 - Assembly-IS 3700 NORMAL TIP2025-12-12
00693856000203 - Assembly-IS 3700 SIDE TIP2025-12-12
00693856000227 - Assembly-IS 3700 POSTERIOR TIP2025-12-12
00693856000258 - Assembly-IS 3800 NORMAL TIP2025-12-12
00693856000272 - Assembly-IS 3800 SIDE TIP2025-12-12

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