510(k) · Cleared
ClearedDental Matrix Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fly Cast Technologies, Inc. · DZN Instruments, Dental Hand
Cleared on Aug 31, 2007 after a 57-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 31, 2007
- Review
- 57 days
- Class
- Class I
- Product code
- DZN
- 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 DZN? 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? (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 |
|---|---|---|---|
| * | — | Dentsply, Inc., Dental Matrix Band 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 DZN devicesDZN Instruments, Dental Hand: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DZN
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · DZN
Too few DZN 510(k)s in any year since 2007 to give a median.
Recalls per year · DZN
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZN
30in 2025
MAUDE reports naming product code DZN, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 79 |
| 2014 | 0 | — | 0 | 76 |
| 2015 | 0 | — | 1 | 51 |
| 2016 | 0 | — | 0 | 30 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 0 | — | 0 | 21 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 0 | — | 0 | 38 |
| 2024 | 0 | — | 0 | 69 |
| 2025 | 0 | — | 0 | 30 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A dental matrix band is a non-sterile single use disposable device intended to be place around a tooth to keep filling material from bonding onto the other tooth. Matrix bands are used to form missing walls of prepared teeth. They shape and confine restorative materials to areas prepared to receive restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071858: Dental Matrix Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071858
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026