510(k) · Cleared
ClearedSlicks Sectional Matrix and Matrix Bands, Models SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 and SMH200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Garrison Dental Solutions · JEP Retainer, Matrix
Cleared on Aug 17, 2009 after an 83-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 17, 2009
- Review
- 83 days
- Class
- Class I
- Product code
- JEP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 JEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Garrison Composi-Tight Sectional matrix bands Named without a submission number | |
| * | — | Waterpik Tofflemire bands Named without a submission number | |
| * | — | Young Dental Ho bands Named without a submission number | |
| * | — | Danville Sectional Matrix Bands Named without a submission number |
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.
How does its category compare?
All JEP devicesJEP Retainer, Matrix: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JEP
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · JEP
Too few JEP 510(k)s in any year since 2007 to give a median.
Recalls per year · JEP
No recall names JEP since 2007.
Adverse event reports per year · JEP
8in 2023
MAUDE reports naming product code JEP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091533: Slicks Sectional Matrix and Matrix Bands, Models SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 and SMH200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091533
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026