510(k) · Cleared
ClearedBetter Diagnostics Dental Assist (BDDA) Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Better Diagnostics AI Corp. · MYN Analyzer, Medical Image
Cleared on Jul 15, 2026 as substantially equivalent to K210365 (Pearl, Inc., 2022) and 1 other predicate after a 121-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Jul 15, 2026
- Review
- 121 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K930527 (1993). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK930527 Dental LinkEscan, Inc. · 1993
- 5 generations between
- 3 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 2 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 1 generation backK210187 Overjet Dental AssistOverjet, Inc. · 2021
- This deviceK260851 Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp. · 2026
Show all 9 generations
- Root · 9 generations backK930527 Dental LinkEscan, Inc. · 1993
- 8 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 7 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 6 generations backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 5 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 4 generations backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- 3 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 2 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 1 generation backK210187 Overjet Dental AssistOverjet, Inc. · 2021
- This deviceK260851 Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −8 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −7 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −6 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −5 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −4 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| −3 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| −2 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −1 | K210187 | Overjet Dental Assist | Overjet, Inc. | 2021 | — |
| 0 (this device) | K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MYN device
- #1 K210365 Second Opinionscore 29.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210365 | Second OpinionSummary page 6…USA Regulation Class: Class II Product Code: MYN 3. Predicate Device Proprietary Name of Device: Second Opinion Premarket Notification: K210365 Regulation Name: Medical Image Analyzer Classification Panel: Radiology Regulation Number: 21 CFR § 892.2070 Regu… | 2022 |
| * | K210187 | Overjet Dental AssistSummary page 6…892.2070 Regulation Class: Class II Product Code: MYN 4. Predicate Device Proprietary Name of Device: Overjet Dental Assist Premarket Notification: K210187 Regulation Name: Medical image management and processing system. Classification Panel: Radiology Regulation Number: 2… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 8 other devices also cite its predicate K210365.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
What is it indicated for?
Better Diagnostics Dental Assist (BDDA) Version 1.0 is a computer aided detection ("CADe”) software intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. The device is also intended to identify and mark regions in relation to suspected dental findings which include marginal discrepancy, calculus, periapical radiolucency (Only IOPA), crowns, filling…
Read the full statement (128 words)
Better Diagnostics Dental Assist (BDDA) Version 1.0 is a computer aided detection ("CADe”) software intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. The device is also intended to identify and mark regions in relation to suspected dental findings which include marginal discrepancy, calculus, periapical radiolucency (Only IOPA), crowns, filling and root canals. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists. The intended patient population of the device is patients who are 18 years or older and do not have any remaining primary teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260851: Better Diagnostics Dental Assist (BDDA) Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260851
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026