510(k) · Cleared

Cleared

TPH Spectra+ Universal Composite Restorative

K162107510(k) TraditionalCleared Sep 27, 201660-day reviewClass II21 CFR 872.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dentsply Sirona · EBF Material, Tooth Shade, Resin

Cleared on Sep 27, 2016 as substantially equivalent to K083610 (3M Company, 2008) after a 60-day review. Its family tree reaches back 1 generation to 2008.

Decided: Sep 27, 2016
Review: 60 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K083610 (2008). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK083610 Filtek Supreme Ultra Universal Restorative3M Company · 2008
This deviceK162107 TPH Spectra+ Universal Composite RestorativeDentsply Sirona · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K083610	Filtek Supreme Ultra Universal Restorative	3M Company	2008	—
0 (this device)	K162107	TPH Spectra+ Universal Composite Restorative	Dentsply Sirona	2016	—

FIG. 1 — Lineage of K162107, 2008–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 EBF? 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 EBF device

#1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K083610	Filtek Supreme Ultra Universal Restorative Summary page 4 …Predicate Device Name 510(k) Company Name TM Filtek Supreme Ultra Universal Restorative K083610 3M ESPE Description of Device: TPH Spectra® + Universal Composite Restorative is a visible light cured, radiopaque, compo…	3M Company	2008	—

Also cleared against K083610: 10 other devices →

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.
10 other devices also cite its predicate K083610.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)2025

MAUDE reports naming product code EBF, 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	19	49	1	6
2008	14	79	42	10
2009	20	84	1	8
2010	19	75	6	31
2011	19	81	7	31
2012	11	86	0	62
2013	13	153	0	246
2014	10	112	0	195
2015	17	123	0	119
2016	20	205	0	143
2017	15	108	4	42
2018	15	115	0	8
2019	17	159	2	11
2020	15	190	1	2
2021	13	178	0	2
2022	17	63	0	2
2023	9	87	0	8
2024	18	120	0	5
2025	15	43	0	1
2026	16	59	2	—

What is it indicated for?

TPH Spectra® + Universal Composite Restorative is indicated for direct or indirect replacement of missing or deficient tooth structure in primary and permanent anterior and posterior teeth, e.g.,

1. Direct anterior and posterior restorations (including occlusal surfaces)

2. Core build-ups

3. Splinting

4. Indirect restorations including inlays, onlays

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/K162107 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162107: TPH Spectra+ Universal Composite Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162107

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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