510(k) · Cleared

Cleared

Kerator

K112787510(k) TraditionalCleared Aug 8, 2012317-day reviewClass II21 CFR 872.3630

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

Kj Meditech Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Aug 8, 2012 as substantially equivalent to K994257 (Zest Anchors, Inc., 2000) and 9 other predicates after a 317-day review. Its family tree reaches back 7 generations to 1990. 3 later devices descend from it.

Decided: Aug 8, 2012
Review: 317 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 10

Its longest line of descent runs back 7 generations to K894595 (1990). 46 ancestors in all, the oldest K894844 (1990). 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
5 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
4 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
3 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
2 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
1 generation backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
This deviceK112787 KeratorKj Meditech Co., Ltd. · 2012
Descendant · cites it directly · 0 of its ownK241183 ISO AbutmentSeum Medi Co., Ltd. · 2025
Descendant · cites it directly · 0 of its ownK173141 CSM Submerged3-L Implant SystemCsm Implant · 2018
Descendant · cites it directly · 0 of its ownK132144 KeratorLK Consulting Group USA, Inc. · 2014

Most influential descendants

Showing 3 of 3 · See all

K241183ISO AbutmentSeum Medi Co., Ltd. · 2025 · cites it directly0descendants
K173141CSM Submerged3-L Implant SystemCsm Implant · 2018 · cites it directly0descendants
K132144KeratorLK Consulting Group USA, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−6	K984104	Iti Dental Implant System	Straumann USA	1999	1
−5	K992937	Dental Implant	Nobel Biocare Uas, Inc.	2000	1
−4	K013067	Frialoc Dental Implant System	Friadent GmbH	2002	—
−3	K021318	Xive Dental Implant System	Friadent GmbH	2002	—
−2	K032158	Xive Dental Implant System Multiple	Friadent GmbH	2003	—
−1	K033984	Straumann Dental Implant System	Institut Straumann AG	2004	—
0 (this device)	K112787	Kerator	Kj Meditech Co., Ltd.	2012	—
+1	K241183	ISO Abutment	Seum Medi Co., Ltd.	2025	—
+1	K173141	CSM Submerged3-L Implant System	Csm Implant	2018	—
+1	K132144	Kerator	LK Consulting Group USA, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0
1993	4	0
1994	3	0
1995	3	0
1996	5	0
1997	1	0
1998	2	0
1999	2	0
2000	3	0
2001	4	0
2002	3	0
2003	4	0
2005	1	0
2009	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2018	1	0
2025	1	0

FIG. 1 — Lineage of K112787, 1990–2025Source: 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 NHA? 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 NHA device

#1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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? (10)

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
*	K994257	Locator Implant Anchor Summary page 1 …utment Product Code: NHA Classification regulation: 21CFR872.3630 4. Predicate Device: Locator Implant Anchor by Zest Anchors, Inc. (K994257) Branemark System 3.3mm Fixture by NOBELPHARMA USA, INC.(K944683) Branemark System 4.00 mum Fixture by NOBELP…	Zest Anchors, Inc.	2000	2
*	K944683	Branemark System 3.3MM Fixture Summary page 1 …FR872.3630 4. Predicate Device: Locator Implant Anchor by Zest Anchors, Inc. (K994257) Branemark System 3.3mm Fixture by NOBELPHARMA USA, INC.(K944683) Branemark System 4.00 mum Fixture by NOBELPHARMA USA, INC.(K925764) Branemark System 5.0 X W4rm Fixture by N…	Nobelpharma USA, Inc.	1995	—
*	K925764	Branemark System 4.00 MM Fixture Summary page 1 …t Anchors, Inc. (K994257) Branemark System 3.3mm Fixture by NOBELPHARMA USA, INC.(K944683) Branemark System 4.00 mum Fixture by NOBELPHARMA USA, INC.(K925764) Branemark System 5.0 X W4rm Fixture by NOBELPHARMA USA, INC.(K92576 1) Astratech Implant System by ASTRA TEC…	Nobelpharma USA, Inc.	1993	—
*	K925761	Branemark System 5.0 X 14MM Fixture Summary page 1 …A USA, INC.(K944683) Branemark System 4.00 mum Fixture by NOBELPHARMA USA, INC.(K925764) Branemark System 5.0 X W4rm Fixture by NOBELPHARMA USA, INC.(K92576 1) Astratech Implant System by ASTRA TECH AB (K091239) Replace Tiunite Endosseous Implant by NOBEL BIOCARE UAS…	Nobelpharma USA, Inc.	1993	—
*	K091239	Astra Tech Implant System Summary page 1 …e by NOBELPHARMA USA, INC.(K925764) Branemark System 5.0 X W4rm Fixture by NOBELPHARMA USA, INC.(K92576 1) Astratech Implant System by ASTRA TECH AB (K091239) Replace Tiunite Endosseous Implant by NOBEL BIOCARE UAS INC (K023 113) 4.5.* 6.0mm Dental Implant and 6.0*6.…	Astra Tech AB	2009	—
*	K023113	Replace Tiunite Endosseous Implant Summary page 1 …e by NOBELPHARMA USA, INC.(K92576 1) Astratech Implant System by ASTRA TECH AB (K091239) Replace Tiunite Endosseous Implant by NOBEL BIOCARE UAS INC (K023 113) 4.5.* 6.0mm Dental Implant and 6.0*6.0 mm Dental Implant by BICON, INC.( K050712) Bicon Dental Implant Syste…	Nobel Biocare Uas, Inc.	2002	27
*	K050712	4.5.* 6.0MM Dental Implant and 6.06.0 MM Dental Implant Summary page 1 …1239) Replace Tiunite Endosseous Implant by NOBEL BIOCARE UAS INC (K023 113) 4.5. 6.0mm Dental Implant and 6.0*6.0 mm Dental Implant by BICON, INC.( K050712) Bicon Dental Implant System 3.0mm Bicon Dental Implant (K101849) 51 0(k) Submission.…	Bicon, Inc.	2005	—
*	K101849	Bicon Dental Implant System 3.0MM Bicon Dental Implant Summary page 1 …(K023 113) 4.5.* 6.0mm Dental Implant and 6.0*6.0 mm Dental Implant by BICON, INC.( K050712) Bicon Dental Implant System 3.0mm Bicon Dental Implant (K101849) 51 0(k) Submission. 5 10(k) summary. 1/3 page Parago…	Bicon, LLC	2010	—
*	K953101	Paragon Implant System	Core-Vent Bio-Engineering, Inc.	1995	—
*	K033984	Straumann Dental Implant System Summary page 2 …summary. 1/3 page Paragon Implant System by CORE-VENT BlO-ENOINEERINQ INC. (K953 I0I) ITI Dental Implant System by INSTITUT STRAUMANN AG (K033984) 5. Description: The devices covered in this submission are abutments which are placed into the dental imp…	Institut Straumann AG	2004	—

Also cleared against K994257: 6 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided
K241183	ISO Abutment	Seum Medi Co., Ltd.	2025
K173141	CSM Submerged3-L Implant System	Csm Implant	2018
K132144	Kerator	LK Consulting Group USA, Inc.	2014

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 5 companies; a new generation was cleared every 1.1 years on median.
4 of the 46 ancestors have a recall of any class.
Of its descendants, K241183 (Seum Medi Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K994257.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007high 211 (2021) · low 90 (2008)2026

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

Recalls per year · NHA

1in 2025

2007high 36 (2016) · low 0 (2009)2026

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

Adverse event reports per year · NHA

838in 2025

2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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	38	91	1	1
2008	31	90	2	8
2009	30	95	0	30
2010	19	162	0	61
2011	31	130	5	56
2012	25	171	1	5
2013	22	184	1	143
2014	27	160	0	146
2015	29	151	1	858
2016	38	202	36	314
2017	31	188	2	577
2018	31	200	1	591
2019	28	160	0	530
2020	38	153	7	458
2021	29	211	0	546
2022	33	142	0	497
2023	51	147	3	618
2024	43	158	0	635
2025	40	147	1	838
2026	23	169	3	—

What is it indicated for?

The Kerator is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseoius implants in the mandible or maxilla. The Kerator is compatible with the following fixtures. Kerator Model No. — Fixture Description — Manufacturer B331 - B337 — Branemark 3.3 Type — NOBELPHARMA USA, INC. B401 - B407 — Branemark 4.0 Type — NOBELPHARMA USA, INC. B501 - B507 — Branemark 5.0 Type — NOBELPHARMA USA, INC. AS351 - AS357 — Astra…

Read the full statement (194 words)

The Kerator is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseoius implants in the mandible or maxilla.

The Kerator is compatible with the following fixtures.

Kerator Model No. — Fixture Description — Manufacturer

B331 - B337 — Branemark 3.3 Type — NOBELPHARMA USA, INC.

B401 - B407 — Branemark 4.0 Type — NOBELPHARMA USA, INC.

B501 - B507 — Branemark 5.0 Type — NOBELPHARMA USA, INC.

AS351 - AS357 — Astra 3.5 Type — ASTRA TECH AB

AS401 - AS407 — Astra 4.0 Type — ASTRA TECH AB

G400 - G406 — Astra 4.0 Type — ASTRA TECH AB

SRS350 - SRS356 — Replace 3.5 Type — Nobel Biocare USA, Inc.

SRS450 - SRS457 — Replace 4.3 Type — Nobel Biocare USA, Inc.

SRS500 - SRS506 — Replace 5.0 Type — Nobel Biocare USA, Inc.

BC201 - BC207 — Bicon 2.0 Type — BICON, INC.

BC301 - BC307 — Bicon 3.0 Type — BICON, INC.

PA350 - PA356 — Paragon 3.5 Type — CORE-VENT ENGINEERING, INC.

PA450 - PA456 — Paragon 4.5 Type — CORE-VENT ENGINEERING, INC.

T40 — ITI 4.0 Type — INSTITUT STRAUMANN AG

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112787 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112787: Kerator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112787

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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