510(k) · Cleared
ClearedApex Dental Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masterlink, LLC · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Feb 28, 2017 as substantially equivalent to K151926 (Denterprise International, Inc., 2015) after a 99-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 28, 2017
- Review
- 99 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933455 (1994). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 5 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 4 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 3 generations backK103290 Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011
- 2 generations backK150823 EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015
- 1 generation backK151926 QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015
- This deviceK163282 Apex Dental SensorsMasterlink, LLC · 2017
- Descendant · cites it directly · 0 of its ownK202369 RXS 1000Rolence Enterprise, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK190234 ODI HD Dental SensorCnd Global Technologies, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −5 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −4 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −3 | K103290 | Edlen Imaging - Gemini Dusb | Edlen Imaging, LLC | 2011 | — |
| −2 | K150823 | EDLENi Intra-Oral Sensor | Edlen Imaging, LLC | 2015 | — |
| −1 | K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | 2015 | — |
| 0 (this device) | K163282 | Apex Dental Sensors | Masterlink, LLC | 2017 | — |
| +1 | K202369 | RXS 1000 | Rolence Enterprise, Inc. | 2021 | — |
| +1 | K190234 | ODI HD Dental Sensor | Cnd Global Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K151926 | QuickRay HD Intraoral SensorSummary page 4…FR 872.1800 Number: Product Code: MUH Classification Dental Panel: Predicate Device Information QuickRay HD Intraoral Sensor (K151926) Device Description The Apex Dental Sensors is an electronic medical device used to acquire intra-oral radiographic images. The… | 2015 |
| † | K983111 | Xray Vision | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K202369 (Rolence Enterprise, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K151926.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Apex Dental Sensors is intended to be used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163282: Apex Dental Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163282
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026