510(k) · Cleared

Cleared

Astralis 7, Model 557545

K013277510(k) TraditionalCleared Oct 22, 200120-day reviewClass II21 CFR 872.6070

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

Ivoclar Vivadent, Inc. · EBZ Activator, Ultraviolet, For Polymerization

Cleared on Oct 22, 2001 after a 20-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 26 later devices descend from it.

Decided: Oct 22, 2001
Review: 20 days
Class: Class II
Product code: EBZ
Recalls: None
Predicates: 0

26 later devices descend from it, 1 citing it directly.

This deviceK013277 Astralis 7, Model 557545Ivoclar Vivadent, Inc. · 2001
Descendant · cites it directly · 25 of its ownK073033 Legacy Dental ImplantsImplant Direct, LLC · 2007
Descendant · 2 generations on · 22 of its ownK090234 Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · Recalled
Descendant · 3 generations on · 10 of its ownK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
Descendant · 4 generations on · 8 of its ownK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
Descendant · 5 generations on · 6 of its ownK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2007high 4 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 26 · See all

K073033Legacy Dental ImplantsImplant Direct, LLC · 2007 · cites it directly25descendants
K090234Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · 2 generations on22descendants
K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · 3 generations on10descendants
K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015 · 4 generations on8descendants
K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018 · 5 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013277	Astralis 7, Model 557545	Ivoclar Vivadent, Inc.	2001	—
+1	K073033	Legacy Dental Implants	Implant Direct, LLC	2007	—
+2	K090234	Spectra System Dental Implants 2008	Implant Direct, LLC	2009	11
+3	K130572	Interactive/ SWISHPLUS2 Implant System	Implant Direct Sybron Manufacturing, LLC	2013	4
+4	K143011	2014 InterActive/SwishActive System	Implant Direct Sybron Manufacturing, LLC	2015	—
+5	K181359	InterActive SMARTBase Abutments	Implant Direct Sybron Manufacturing, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0
2013	3	0
2015	1	0
2016	2	0
2017	1	0
2018	2	0
2019	1	0
2020	3	0
2021	1	0
2022	1	0
2023	4	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K013277, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EBZ? 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 EBZ device

#1 K253131 Curing Light (M-Cure 6)score 12.7 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (26)

See all 26

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073033	Legacy Dental Implants	Implant Direct, LLC	2007	25

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?

Of its descendants, K073033 (Implant Direct, LLC, 2007) has gone furthest, with 25 descendants of its own.

How does its category compare?

All EBZ devices

EBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBZ

4in 2025

2007high 10 (2007) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBZ

105in 2025

2007high 289 (2014) · low 47 (2007)2026

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

Recalls per year · EBZ

1in 2022

2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · EBZ

1in 2025

2007high 31 (2014) · low 0 (2019)2025

MAUDE reports naming product code EBZ, 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	10	47	0	1
2008	5	75	0	7
2009	4	69	0	5
2010	1	—	0	5
2011	3	137	0	18
2012	1	—	1	20
2013	3	171	0	27
2014	3	289	0	31
2015	4	252	0	8
2016	4	251	0	3
2017	8	158	0	5
2018	2	—	1	3
2019	5	145	0	0
2020	5	164	0	2
2021	1	—	0	4
2022	5	144	1	5
2023	3	255	0	7
2024	1	—	0	3
2025	4	105	0	1
2026	1	—	0	—

What is it indicated for?

Astralis 7 is a hand held polymerization unit used to cure dental composites

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013277 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013277: Astralis 7, Model 557545.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013277

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026