510(k) · Cleared

Cleared

Metacem, Meta P&Bond, Metacem Silane Ceramic Primer

K081913510(k) TraditionalCleared Sep 5, 200864-day reviewClass II21 CFR 872.3275

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. · EMA Cement, Dental

Cleared on Sep 5, 2008 as substantially equivalent to K073173 (Dentsply Interntional, 2008) and 12 other predicates after a 64-day review. Its family tree reaches back 8 generations to 1993. 3 later devices descend from it.

Decided: Sep 5, 2008
Review: 64 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 13

Its longest line of descent runs back 8 generations to K931812 (1993). 47 ancestors in all, the oldest K871636 (1987). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 8 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
7 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
6 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
5 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
4 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
3 generations backK990040 Clearfil SE BondKuraray Co. · 1999
2 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
1 generation backK024356 Clearfil Silane KitKuraray Medical, Inc. · 2003
This deviceK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
Descendant · cites it directly · 1 of its ownK171449 MetacemMeta Biomed Co., Ltd. · 2018
Descendant · 2 generations on · 0 of its ownK261166 Dia-CemDiaDent Group International · 2026
Descendant · cites it directly · 0 of its ownK180802 Meta P&BondMeta Biomed Co., Ltd. · 2018

Most influential descendants

Showing 3 of 3 · See all

K171449MetacemMeta Biomed Co., Ltd. · 2018 · cites it directly1descendant
K261166Dia-CemDiaDent Group International · 2026 · 2 generations on0descendants
K180802Meta P&BondMeta 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
−8	K931812	New Dentine Adhesive	Dentsply Intl.	1993	—
−7	K960823	Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−6	K962348	Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−5	K964525	Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator	Dentsply Intl.	1997	—
−4	K974486	Clearfil Liner Bond 2V	Kuraray America, Inc.	1998	—
−3	K990040	Clearfil SE Bond	Kuraray Co.	1999	—
−2	K012442	Modification to Clearfil SE Bond	Kuraray Medical, Inc.	2001	—
−1	K024356	Clearfil Silane Kit	Kuraray Medical, Inc.	2003	—
0 (this device)	K081913	Metacem, Meta P&Bond, Metacem Silane Ceramic Primer	Meta Biomed Co., Ltd.	2008	—
+1	K171449	Metacem	Meta Biomed Co., Ltd.	2018	—
+2	K261166	Dia-Cem	DiaDent Group International	2026	—
+1	K180802	Meta P&Bond	Meta Biomed Co., Ltd.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1988	1	0
1990	3	0
1991	1	0
1992	1	0
1993	2	0
1994	6	0
1995	2	0
1996	1	0
1998	2	0
2000	1	0
2001	4	0
2002	2	0
2003	1	0
2004	3	0
2005	1	0
2006	5	0
2007	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	2	0
2026	1	0

FIG. 1 — Lineage of K081913, 1993–2026Source: 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 EMA? 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 EMA device

#1 K254109 G-Cem Universalscore 15.0 · 13 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? (13)

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
*	K073173	Self-Adhesive Resin Cement Summary page 1 …ent to several devices currently on the market that have been cleared by the premarket notification-510(k) process. Some of these are outlined below: 1. K073173, Self-Adhesive Resin Cement, Dentsply, Intl., 2. K060703, Biscem Translucent, Biscem Opaque, Bisco, Inc., 3. K060…	Dentsply Interntional	2008	—
*	K060701	Biscem Translucent, Biscem Opaque Our reading of the summary gave K060703, FDA’s number for PMP4 BP Pro Blood Pressure Monitor (Card Guard Scientific Survival, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Biscem Translucent, Biscem Opaque”.	Bisco, Inc.	2006	2
*	K060698	Cement-IT All Purpose, Model N97 Summary page 1 …these are outlined below: 1. K073173, Self-Adhesive Resin Cement, Dentsply, Intl., 2. K060703, Biscem Translucent, Biscem Opaque, Bisco, Inc., 3. K060698, Cement-It All Purpose, Pentron Clinical Technologies, 4. K053040, Paracem Universal DC, Coltene/Whaledent AG, and…	Pentron Clinical Technologies	2006	2
*	K053040	Paracem Universal DC Summary page 1 …Dentsply, Intl., 2. K060703, Biscem Translucent, Biscem Opaque, Bisco, Inc., 3. K060698, Cement-It All Purpose, Pentron Clinical Technologies, 4. K053040, Paracem Universal DC, Coltene/Whaledent AG, and 5. K040906, Calibra Cement, Dentsply, Intl.…	Coltene/Whaledent AG	2005	—
*	K040906	Calibra Cement Summary page 1 …ue, Bisco, Inc., 3. K060698, Cement-It All Purpose, Pentron Clinical Technologies, 4. K053040, Paracem Universal DC, Coltene/Whaledent AG, and 5. K040906, Calibra Cement, Dentsply, Intl. 12 Metacem is substantially equivale…	Dentsply Intl.	2004	—
*	K070215	Tokuyama Bond Force Summary page 3 …o several devices currently on the market that have been cleared by the premarket notification- 510(k) process. Some of these are outlined below: 1. K070215, Tokuyama Bond Force, Tokuyama Dental Corp., 2. K063557, Peak Bond, Ultradent Products, Inc., 3. K01 1159, One-…	Tokuyama Dental Corporation	2007	—
*	K063557	Peak Bond, Model 5133 Summary page 3 …eared by the premarket notification- 510(k) process. Some of these are outlined below: 1. K070215, Tokuyama Bond Force, Tokuyama Dental Corp., 2. K063557, Peak Bond, Ultradent Products, Inc., 3. K01 1159, One-Step Plus, Bisco, Inc. and 4. K960823, Prime & Bond 2.0…	Ultradent Products, Inc.	2006	—
*	K011159	One-Step Plus Summary page 3 …Some of these are outlined below: 1. K070215, Tokuyama Bond Force, Tokuyama Dental Corp., 2. K063557, Peak Bond, Ultradent Products, Inc., 3. K01 1159, One-Step Plus, Bisco, Inc. and 4. K960823, Prime & Bond 2.0 Multipurpose, Dentsply, Intl. Meta P&Bond is subst…	Bisco, Inc.	2001	—
*	K960823	Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent Summary page 3 …5, Tokuyama Bond Force, Tokuyama Dental Corp., 2. K063557, Peak Bond, Ultradent Products, Inc., 3. K01 1159, One-Step Plus, Bisco, Inc. and 4. K960823, Prime & Bond 2.0 Multipurpose, Dentsply, Intl. Meta P&Bond is substantially equivalent (and most similar) to One-Step P…	Dentsply Intl.	1996	—
*	K061906	Clearfil Ceramic Primer Summary page 5 …veral devices currently on the market that have been cleared by the premarket notification-510(k) process. Some of these are outlined below 1. K061906, Clearfil CeramicPrimer, Kuraray Medical Inc., 2. K061322, Porcelain Primer, J. Morita USA, Inc., 3.…	Kuraray Medical, Inc.	2006	—
*	K061322	Porcelain Primer Summary page 5 …e premarket notification-510(k) process. Some of these are outlined below 1. K061906, Clearfil CeramicPrimer, Kuraray Medical Inc., 2. K061322, Porcelain Primer, J. Morita USA, Inc., 3. K024356, Clearfil Silane Kit, Kuraray Medical Inc. and 4.…	J. Morita USA, Inc.	2006	—
*	K024356	Clearfil Silane Kit Summary page 5 …outlined below 1. K061906, Clearfil CeramicPrimer, Kuraray Medical Inc., 2. K061322, Porcelain Primer, J. Morita USA, Inc., 3. K024356, Clearfil Silane Kit, Kuraray Medical Inc. and 4. K954708, Silane Primer, Sybron Dental Specialties, Inc. T…	Kuraray Medical, Inc.	2003	—
*	K954708	Silane Primer Summary page 5 …y Medical Inc., 2. K061322, Porcelain Primer, J. Morita USA, Inc., 3. K024356, Clearfil Silane Kit, Kuraray Medical Inc. and 4. K954708, Silane Primer, Sybron Dental Specialties, Inc. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed)…	Sybron Dental Specialties, Inc.	1995	—

Also cleared against K073173: 1 other device →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K171449	Metacem	Meta Biomed Co., Ltd.	2018	1
K180802	Meta P&Bond	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 15 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
2 of the 47 ancestors have a recall of any class.
Of its descendants, K171449 (Meta Biomed Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K073173.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · EMA

10in 2025

2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007high 245 (2022) · low 48 (2007)2026

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

Recalls per year · EMA

1in 2023

2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EMA

9in 2025

2007high 385 (2013) · low 3 (2022)2025

MAUDE reports naming product code EMA, 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	6	48	0	33
2008	13	71	2	50
2009	10	86	1	90
2010	14	86	1	106
2011	8	79	5	224
2012	10	128	0	249
2013	12	178	0	385
2014	4	174	0	207
2015	9	134	0	85
2016	10	182	0	16
2017	3	141	0	13
2018	3	237	0	4
2019	7	127	0	12
2020	8	164	0	5
2021	4	184	0	8
2022	7	245	0	3
2023	2	—	1	6
2024	3	59	0	5
2025	10	106	0	9
2026	7	150	0	—

What is it indicated for?

Adhesive cementation of: • Crowns & Bridges (ceramic, porcelain, composite and metals), · Inlays/onlays cementation, * Bonding of veneers or crown; PFM, also alumina & zirconia, · Endodontic post cementation, · Core build up. * A dental adhesive formulated to adhesively bond to hard tissues of the oral cavity, enamel and dentin, * Dentin-enamel primer/bonding agent for direct composite restorations * Indirect composite restorative luting system *…

Read the full statement (116 words)

Adhesive cementation of:

• Crowns & Bridges (ceramic, porcelain, composite and metals),

· Inlays/onlays cementation,

* Bonding of veneers or crown; PFM, also alumina & zirconia,

· Endodontic post cementation,

· Core build up.

* A dental adhesive formulated to adhesively bond to hard tissues of the oral cavity, enamel and dentin,

* Dentin-enamel primer/bonding agent for direct composite restorations

* Indirect composite restorative luting system

* Porcelain veneer luting system

* Bonding composite to composite

* Bonding composite to metal/amalgam

* Adhesive amalgam restoration.

Primer for surfaces of:

* Crowns and bridges, ceramic, composite, porcelain, metal,

* Pre-cured composite inlays and onlays,

* Ceramic inlays and onlays,

* Porcelain veneers,

* Porcelain and metal prosthesis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081913 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081913

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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