510(k) · Cleared
ClearedCompex HD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Addent, Inc. · QGO Composite Resin Warmer
Cleared on Apr 29, 2019 as substantially equivalent to K061395 (Addent, Inc., 2006) after a 276-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Apr 29, 2019
- Review
- 276 days
- Class
- Class I
- Product code
- QGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061395 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK061395 Calset Composite HeaterAddent, Inc. · 2006
- This deviceK182017 Compex HDAddent, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061395 | Calset Composite Heater | Addent, Inc. | 2006 | — |
| 0 (this device) | K182017 | Compex HD | Addent, Inc. | 2019 | — |
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 QGO? 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 |
|---|---|---|---|
| * | K061395 | Calset Composite HeaterSummary page 4…mon Name: Composite Warmer Classification Name: Anesthetic warmer (21 CFR 872.6100 ) Product Code QGO Marketed Device of Equivalence: Calset composite heater, 510(k) # K061395, Classification product code: EBZ (Activator, Ultraviolet, For Polymerization, 21 CFR 872.670), Subsequent product codes: EEG (He… | 2006 |
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?
- Its one ancestor has no recall.
How does its category compare?
All QGO devicesQGO Composite Resin Warmer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QGO
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QGO
Too few QGO 510(k)s in any year since 2007 to give a median.
Recalls per year · QGO
No recall names QGO since 2007.
Adverse event reports per year · QGO
No MAUDE report names QGO since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Compex HD is intended to be used by a dentist or health care provider to warm and dispense dental composite materials contained in a compule or PLT (Pre Loaded Tip) to 155 degrees F (68 degrees C).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182017 · printed Nov 3, 2026
Cite this page
510(k) Report. “K182017: Compex HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K182017
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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