510(k) · Cleared

Cleared

LOCATOR R-Tx

K200827510(k) SpecialCleared Sep 2, 2020156-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

Ivory Super Holdco, Incp. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Sep 2, 2020 as substantially equivalent to K150295 (Zest Anchors, Inc., 2015) after a 156-day review. Its family tree reaches back 13 generations to 1990. 1 later device descends from it.

Decided: Sep 2, 2020
Review: 156 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 1

Its longest line of descent runs back 13 generations to K894595 (1990). 152 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
9 generations between
3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
1 generation backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
This deviceK200827 LOCATOR R-TxIvory Super Holdco, Incp. · 2020
Descendant · cites it directly · 0 of its ownK253774 Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S · 2026

Show all 13 generations

Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
10 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
9 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
8 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
7 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
6 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
5 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
4 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
1 generation backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
This deviceK200827 LOCATOR R-TxIvory Super Holdco, Incp. · 2020

Most influential descendants

Showing 1 of 1 · See all

K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−13	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−12	K984104	Iti Dental Implant System	Straumann USA	1999	1
−11	K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…	Nobel Biocare Uas, Inc.	2000	—
−10	K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	2002	27
−9	K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	2004	—
−8	K050258	Groovy Implants	Nobel Biocare AB	2005	28
−7	K061003	SFB & CFB Implants	Nobel Biocare AB	2006	—
−6	K071370	Nobelactive Internal Connection Implant	Nobel Biocare AB	2007	4
−5	K101732	Astra Tech Implant System	Astra Tech AB	2011	—
−4	K111287	Astra Tech Implant System	Astra Tech AB	2011	—
−3	K112138	Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant	Astra Tech, Inc.	2011	—
−2	K120414	Osseospeed Plus	Astra Tech AB	2012	—
−1	K150295	LOCATOR RTx	Zest Anchors, Inc.	2015	—
0 (this device)	K200827	LOCATOR R-Tx	Ivory Super Holdco, Incp.	2020	—
+1	K253774	Elos Accurate® Denture Fixation System	Elos Medtech Pinol A/S	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1982	1	0
1985	1	0
1986	2	0
1987	2	0
1988	1	0
1989	5	0
1990	5	0
1991	1	0
1992	2	0
1993	11	0
1994	10	0
1995	10	0
1996	11	0
1997	6	0
1998	7	0
1999	7	0
2000	3	0
2001	3	0
2002	11	0
2003	7	0
2004	5	0
2005	4	0
2006	1	0
2007	6	0
2008	4	0
2009	3	0
2010	5	0
2011	3	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K200827, 1990–2026Source: 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 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

Get a 510(k) Report

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
*	K150295	LOCATOR RTx Summary page 5 …subject device is similar in design to the predicate device and identical to the predicate in regards to the abutment-implant interface as described in K150295. IV. DEVICE DESCRIPTION LOCATOR R-Tx implant attachment system, consists of abutments, nylon or PEEK line…	Zest Anchors, Inc.	2015	—

Also cleared against K150295: 2 other devices →

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
K253774	Elos Accurate® Denture Fixation System	Elos Medtech Pinol A/S	2026	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 30 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
16 of the 152 ancestors have a recall of any class.
Of its descendants, K253774 (Elos Medtech Pinol A/S, 2026) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K150295.

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. 2020, 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 LOCATOR R-Tx® Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. LOCATOR R-Tx Attachment System is compatible with the following implant systems: Implant Manufacturer: Implant System: Implant Diameters (Ø mm): Ace Surgical Infinity OCTAGON (3.3, 4.1, 4.8) Infinity TRI-CAM (3.5, 4.3, 5.0) Infinity External Hex (3.3, 3.75, 4.0, 4.75) Infinity…

Read the full statement (340 words)

Implant Manufacturer: Implant System: Implant Diameters (Ø mm):

Ace Surgical Infinity OCTAGON (3.3, 4.1, 4.8)

Infinity TRI-CAM (3.5, 4.3, 5.0)

Infinity External Hex (3.3, 3.75, 4.0, 4.75)

Infinity Internal Hex (3.7, 4.1, 4.7, 5.1)

Avinent Biomimetic Ocean (3.3, 3.5, 4.0, 4.5, 5.0)

Biomimetic Coral (3.3, 3.8, 4.0, 4.2, 4.8)

Biohorizons Tapered Internal (3.0)

Tapered Plus (3.8)

Laser-Lok (3.0)

Biomet 3i 3iT3, NanoTite, OSSEOTITE (3.25, 3.75, 4.0)

Blue Sky Bio Quattro (3.3, 4.1, 4.8)

One Stage (3.3, 4.1, 4.8)

Camlog SCREW-LINE ROOT-LINE 2 (3.3, 3.8, 4.3, 5.0)

SCREW-LINE (3.3, 3.8, 4.3, 5.0)

Dentsply Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8)

Xive Frialit-2 (3.4, 3.8, 4.5, 5.5)

Ankylos C/X (3.5)

Astra Tech OsseoSpeed TX (3.5, 4.0, 4.5, 5.0)

Hiossen, Inc. SS (3.5, 4.0, 4.5)

ET, TS (3.5, 4.0, 4.5, 5.0, 6.0, 7.0)

US (3.5, 3.3, 4.5, 4.0, 5.0, 6.0, 7.0)

Implant Direct Swish Plus (4.1, 4.8)

SwishTapered (4.1, 4.8)

InterActive (3.2, 3.7, 4.3, 5.0)

ReActive (3.7, 4.2, 4.7, 5.7)

Replant (3.5, 4.3, 5.0)

Legacy 1, 2, 3, 4 (3.7, 4.2)

Legacy 2, 3, 4 (3.2, 4.7, 5.2)

Legacy 1, 3 (5.7)

Legacy 2, 4 (5.7, 7.0)

Legacy 1 (4.7)

IDS MegaGen Any Ridge (3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0)

Keystone PrimaConnex (3.5, 4.1, 5.0)

Genesis (3.5)

TILOBEMAXX (7.0, 8.0, 9.0)

MIS C1 (3.3, 3.75, 4.2)

V3 (3.3, 3.9, 4.3, 5.0)

SEVEN (3.3)

M4 (3.3)

Nobel Replace, Replace Select, NobelSpeedy (3.5, 4.3, 5.0)

NobelActive, NobelParallel CC, NobelReplace CC (3.5, 4.3, 5.5)

Branemark, Nobel Speedy, Groovy (3.3, 3.75, 4.0, 5.0)

OCO Biomedical Engage (3.25, 4.0, 5.0)

Southern Implants Tri-Nex (3.5, 4.3, 5.0)

Tri-MAX7 (7.0)

External Hex (3.75, 4.0, 5.0, 5.1, 6.0, 7.0, 8.0)

Straumann Roxolid SLActive, Roxolid SLA (3.3, 4.1, 4.8)

Zimmer Trabecular Metal, Tapered Screw-Vent, Screw-Vent, Advent (3.7, 4.1, 4.7, 6.0)

Spline Reliance Cylinder (3.25, 4.0, 5.0)

Spline Twist (3.75)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200827 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200827: LOCATOR R-Tx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200827

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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