Data / Medical devices / United States / Overjet

Overjet: FDA-registered device maker in Boston, MA, United States, 9 510(k) clearances

Name: Overjet FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Overjet is registered with the FDA (registration 3019544554) in Boston, MA, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3019544554
Address: 200 State St Ste 1220, Boston, MA, United States, 02109
Owner or operator: Overjet (10082112)
Roles: Manufacturer
First device listed: June 16, 2021
Registered through: 2026
Brand names listed: Overjet CBCT Assist, Overjet Calculus Assist, Overjet Caries Assist, Overjet Caries Assist-Pediatric, Overjet Charting Assist, Overjet DI System, Overjet Dental Assist, Overjet Image Enhancement Assist and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Medical Image	MYN	2	Manufacturer	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 10, 2026	K253930	Overjet Iris Intelligent Imaging System	QIH	Substantially Equivalent	Overjet, Inc.	accessdata.fda.gov
December 5, 2025	K251514	Overjet CBCT Assist	QIH	Substantially Equivalent	Overjet, Inc.	accessdata.fda.gov
September 9, 2024	K241681	Overjet Image Enhancement Assist	QIH	Substantially Equivalent	Overjet, Inc.	accessdata.fda.gov
August 27, 2024	K241684	Overjet Charting Assist	QIH	Substantially Equivalent	Overjet, Inc.	accessdata.fda.gov
March 4, 2024	K233738	Overjet Caries Assist-Pediatric	MYN	Substantially Equivalent	Overjet, Inc.	accessdata.fda.gov
September 21, 2023	K231678	Overjet Periapical Radiolucency Assist	MYN	Substantially Equivalent	Overjet, Inc.	accessdata.fda.gov
March 27, 2023	K222746	Overjet Caries Assist	MYN	Substantially Equivalent	Overjet, Inc.	accessdata.fda.gov
December 16, 2022	K220928	Overjet Calculus Assist	MYN	Substantially Equivalent	Overjet, Inc.	accessdata.fda.gov
May 19, 2021	K210187	Overjet Dental Assist	LLZ	Substantially Equivalent	Overjet, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.