510(k) clearances

Overjet Multi-Image Caries and Charting Assist

Overjet, Inc. · Radiology

K261059Substantially EquivalentTraditionalMYN
Open FDA's page for this record
Third party flag
N
City
Boston
Advisory committee description
Radiology
Address 1
200 State St.
Address 2
Suite 1220
Statement or summary
Summary
Product code
MYN
Zip code
02109
Applicant
Overjet, Inc.
Decision date
2026-08-06
Decision code
SESE
Country code
US
Device name
Overjet Multi-Image Caries and Charting Assist
Advisory committee
RA
Contact
Gayatri Sekaran
K number
K261059
State
MA
Date received
2026-03-31
Review advisory committee
RA
Postal code
02109
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Analyzer, Medical Image
Medical specialty description
Radiology
Regulation number
892.2070
Device class
2
Registration number
3026970882, 3022719380, 3008693672, 3029956998, 8020825, 1226003, 3005156333, 3014661828, 3010300212, 3043237021, 3021907554, 3032960222, 3038172231, 3005383085, 3025110425, 3005739655, 3032116890, 3024891354, 9611992, 3021887566, 3029904428, 3014398772, 3038187462, 3005496266, 3012035824, 3026753394, 3019544554, 3017840913
FEI number
7695, 3026970882, 3002807692, 3022719380, 3008693672, 3029956998, 3005156333, 3014661828, 3010300212, 3043237021, 3021907554, 3032960222, 3038172231, 3005383085, 3025110425, 3005739655, 3032116890, 3024891354, 3002522649, 3021887566, 3029904428, 3014398772, 3038187462, 3005496266, 3012035824, 3026753394, 3019544554, 3017840913
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.