510(k) · Cleared
ClearedMaxima-M Straight Attachment, Maxima-M Contra Angle Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Handpiece Headquarters · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Aug 20, 2009 as substantially equivalent to K792445 (Midwest, 1979) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Aug 20, 2009
- Review
- 44 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K792445 (1979). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK792445 MW Straight AttachmentMidwest · 1979
- This deviceK092053 Maxima-M Straight Attachment, Maxima-M Contra Angle SheathHandpiece Headquarters · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792445 | MW Straight Attachment | Midwest | 1979 | — |
| 0 (this device) | K092053 | Maxima-M Straight Attachment, Maxima-M Contra Angle Sheath | Handpiece Headquarters | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 EGS? 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 EGS device
- #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 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 |
|---|---|---|---|
| * | K792445 | MW Straight AttachmentSummary page 1…872.4200), Class 1, Product Code EGS e- Substantial Equivalency is claimed against the following devices: MIDWEST STRAIGHT ATTACHMENT-K792445 NSK CONTRAANGLE SHEATH-K962540 f- Description of the device: The Straight Attachment or th… | 1979 |
| * | K962540 | E-Type Contra Angle Nac-ESummary page 1…is claimed against the following devices: MIDWEST STRAIGHT ATTACHMENT-K792445 NSK CONTRAANGLE SHEATH-K962540 f- Description of the device: The Straight Attachment or the Contra Angle sheath is used to connect… | 1996 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K792445.
How does its category compare?
All EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Straight Attachment and Contra Angle Sheath attachments are used with a Low Speed Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
These attachments are used by authorized persons in the practice of dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092053: Maxima-M Straight Attachment, Maxima-M Contra Angle Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092053
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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