Overjet Caries Assist

GUDID 00860005586318

Overjet, Inc.

Dental x-ray image interpretive software
Primary Device ID00860005586318
NIH Device Record Key2955dac7-4095-448a-99e2-7495d1cf6862
Commercial Distribution StatusIn Commercial Distribution
Brand NameOverjet Caries Assist
Version Model Numberv1
Company DUNS116916753
Company NameOverjet, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860005586318 [Primary]

FDA Product Code

MYNAnalyzer, Medical Image

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-20
Device Publish Date2024-11-12

Devices Manufactured by Overjet, Inc.

00860005586301 - Overjet Dental Assist2024-11-20
00860005586318 - Overjet Caries Assist2024-11-20
00860005586318 - Overjet Caries Assist2024-11-20
00860005586325 - Overjet Calculus Assist2024-11-20
00860005586332 - Overjet Periapical Radiolucency Assist2024-11-20
00860005586349 - Overjet DI System2024-11-20
00860005586356 - Overjet Charting Assist2024-11-20
00860005586363 - Overjet Caries Assist-Pediatric2024-11-20
00860005586370 - Overjet Image Enhancement Assist2024-11-20

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