510(k) · Cleared

Cleared

Nexcomp and Meta Etchant

K080305510(k) TraditionalCleared Apr 7, 200862-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

Meta Biomed Co., Ltd. · EBF Material, Tooth Shade, Resin

Cleared on Apr 7, 2008 as substantially equivalent to K070583 (Cosmedent, Inc., 2007) and 5 other predicates after a 62-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it.

Decided: Apr 7, 2008
Review: 62 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K863092 (1986). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK863092 Dental Composite RestorativeDentsply Intl. · 1986
3 generations backK973221 Composite 168 Restorative SystemDentsply Intl. · 1998
2 generations backK984387 R-30 Aesthetic RestorativeDentsply Intl. · 1999
1 generation backK052097 Ceram X Universal Mano-Ceramic RestorativeDentsply International · 2005
This deviceK080305 Nexcomp and Meta EtchantMeta Biomed Co., Ltd. · 2008
Descendant · cites it directly · 0 of its ownK181689 NexcompMeta Biomed Co., Ltd. · 2018

Most influential descendants

Showing 1 of 1 · See all

K181689NexcompMeta Biomed Co., Ltd. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K863092	Dental Composite Restorative	Dentsply Intl.	1986	—
−3	K973221	Composite 168 Restorative System	Dentsply Intl.	1998	—
−2	K984387	R-30 Aesthetic Restorative	Dentsply Intl.	1999	—
−1	K052097	Ceram X Universal Mano-Ceramic Restorative	Dentsply International	2005	—
0 (this device)	K080305	Nexcomp and Meta Etchant	Meta Biomed Co., Ltd.	2008	—
+1	K181689	Nexcomp	Meta Biomed Co., Ltd.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1998	1	0
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K080305, 1986–2018Source: 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? (6)

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
*	K070583	Nano Composite Summary page 1 …on the market that have been cleared by the premarket notification-5I 0(k) process. Some of these are outlined below: 1. K070583, Nano Composite, Cosmedent, Inc., 10 2. K052097, Ceram X…	Cosmedent, Inc.	2007	—
*	K052097	Ceram X Universal Mano-Ceramic Restorative Summary page 2 …ned below: 1. K070583, Nano Composite, Cosmedent, Inc., 10 2. K052097, Ceram X Universal Mano-Ceramic Restorative, Dentsply, Inc. 3. K003361, Renew LS-2, Bisco, Inc., 4. K9827…	Dentsply International	2005	—
*	K003361	Renew LS-2 Summary page 2 …c., 10 2. K052097, Ceram X Universal Mano-Ceramic Restorative, Dentsply, Inc. 3. K003361, Renew LS-2, Bisco, Inc., 4. K982729, Renew, Bisco, Inc. The "510(k) "Substantial Equivalence" Decision-Making Process (D…	Bisco, Inc.	2000	—
*	K982729	RENEW Summary page 2 …10 2. K052097, Ceram X Universal Mano-Ceramic Restorative, Dentsply, Inc. 3. K003361, Renew LS-2, Bisco, Inc., 4. K982729, Renew, Bisco, Inc. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3…	Bisco, Inc.	1998	—
*	K062409	K-Etchant Gel Summary page 3 …t that have been cleared by the premarket notification-510(k) process. For Meta Etchant, some predicates are: 1. K062409, K-Etchant Gel, Kuraray Medical Inc., 2. K022492, Pulpdent Semi-Gel Etch, Pulpdent Corporation,…	Kuraray Medical, Inc.	2006	—
*	K022492	Pulpdent Semi-Gel Etch Summary page 3 …0(k) process. For Meta Etchant, some predicates are: 1. K062409, K-Etchant Gel, Kuraray Medical Inc., 2. K022492, Pulpdent Semi-Gel Etch, Pulpdent Corporation, The "510(k) "Substantial Equivalence" Decision-Making Process (Detai…	Pulpdent Corporation	2002	—

Also cleared against K070583: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K181689	Nexcomp	Meta Biomed Co., Ltd.	2018	0

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?

The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
None of the 14 ancestors has a recall.
Of its descendants, K181689 (Meta Biomed Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K070583.

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. 2008, 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?

Meta Etchant is intended for use in dentin/enamel etching to prepare the tooth surface for application of a bonding agent.

Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class 1,11, 111, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diastema closure, direct veneers, composite and porcelain repairs.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080305 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080305: Nexcomp and Meta Etchant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080305

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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