510(k) · Cleared
ClearedNew Stetic Dental Amalgam Alloy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Stetic · OIV Dental Amalgam
Cleared on Apr 29, 2014 as substantially equivalent to K940675 (Sybron Dental Specialties, Inc., 1994) and 2 other predicates after a 103-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Apr 29, 2014
- Review
- 103 days
- Class
- Class II
- Product code
- OIV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K802967 (1980). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK802967 Dispersalloy-Dispersed Phase Alloy Self-Johnson & Johnson Professionals, Inc. · 1980
- This deviceK140125 New Stetic Dental Amalgam AlloyNew Stetic · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802967 | Dispersalloy-Dispersed Phase Alloy Self- | Johnson & Johnson Professionals, Inc. | 1980 | — |
| 0 (this device) | K140125 | New Stetic Dental Amalgam Alloy | New Stetic | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1994 | 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 OIV? 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 OIV device
- #1 K223182 Arial Dental, Mistral Dental Amalgam, World…score 5.3 · 1 generation · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K940675 | SybraloySummary page 2…pecial Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff was used Predicate Device: K940675 - Sybraloy K8201 81 - SybronlKerr Contour K820967… | 1994 |
| * | K820181 | Sybron/Kerr ContourSummary page 2…and Amalgam Alloy - Guidance for Industry and FDA Staff was used Predicate Device: K940675 - Sybraloy K8201 81 - SybronlKerr Contour K820967 - Dispersalloy-Dispersed Phase Alloy Substantial Equiva… | 1982 |
| * | K802967 | Dispersalloy-Dispersed Phase Alloy Self- Our reading of the summary gave K820967, FDA’s number for Biopsy Forceps W/Alligator Type Cups (Mill-Rose Laboratory). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Dispersalloy-Dispersed Phase Alloy”. | 1980 |
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 3 ancestors has a recall.
How does its category compare?
All OIV devicesOIV Dental Amalgam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OIV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OIV
Too few OIV 510(k)s in any year since 2007 to give a median.
Recalls per year · OIV
No recall names OIV since 2007.
Adverse event reports per year · OIV
1in 2024
MAUDE reports naming product code OIV, 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 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
New Stetic NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic Dental Amalgam Alloys are commonly used as a filling material for restoring the morphology and function of posterior teeth (cavities class I and 11in molars and premolars), when these have lost their structure due to injuries such as cavities or fractures.
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/K140125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140125: New Stetic Dental Amalgam Alloy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140125
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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