510(k) · Cleared

Cleared

Biohorizons Tapered Internal Plus Implants

K121787510(k) SpecialCleared Sep 5, 201279-day reviewClass II21 CFR 872.3640

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

BioHorizons Implant Systems, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Sep 5, 2012 as substantially equivalent to K071638 (BioHorizons Implant Systems, Inc., 2007) after a 79-day review. Its family tree reaches back 1 generation to 2007. 13 later devices descend from it.

Decided: Sep 5, 2012
Review: 79 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K071638 (2007). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK071638 Biohorizons Tapered Internal Implant SystemBioHorizons Implant Systems, Inc. · 2007 · Recalled
This deviceK121787 Biohorizons Tapered Internal Plus ImplantsBioHorizons Implant Systems, Inc. · 2012
Descendant · cites it directly · 10 of its ownK172576 BioHorizons Tapered Short ImplantsBioHorizons Implant Systems, Inc. · 2017
Descendant · 2 generations on · 8 of its ownK203252 Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021
Descendant · 3 generations on · 3 of its ownK213106 BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022
Descendant · 2 generations on · 2 of its ownK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
Descendant · 4 generations on · 2 of its ownK231827 BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2015high 4 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 13 · See all

K172576BioHorizons Tapered Short ImplantsBioHorizons Implant Systems, Inc. · 2017 · cites it directly10descendants
K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021 · 2 generations on8descendants
K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022 · 3 generations on3descendants
K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024 · 2 generations on2descendants
K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K071638	Biohorizons Tapered Internal Implant System	BioHorizons Implant Systems, Inc.	2007	2
0 (this device)	K121787	Biohorizons Tapered Internal Plus Implants	BioHorizons Implant Systems, Inc.	2012	—
+1	K172576	BioHorizons Tapered Short Implants	BioHorizons Implant Systems, Inc.	2017	—
+2	K203252	Multi-unit Abutments for CONELOG	BioHorizons Implant Systems, Inc.	2021	—
+3	K213106	BTI Interna Dental Implant System UnicCa - Prosthetic Components	B.T.I. Biotechnology Institute, Sl.	2022	—
+2	K240187	Tapered Pro Conical Implant System	BioHorizons Implant Systems, Inc.	2024	—
+4	K231827	BTI Dental Implant System UnicCa® – Aesthetic Post Abutments	B.T.I. Biotechnology Institute, Sl.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2017	1	0
2018	1	0
2021	1	0
2022	1	0
2023	2	0
2024	4	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K121787, 2007–2026Source: 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 DZE? 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 DZE device

#1 K211090 ZENEX Implant Systemscore 25.4 · 15 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? (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
*	K071638	Biohorizons Tapered Internal Implant System Summary page 1 …tal implant Classification Number: Class 11 (21 CFR 872.3640) Predicate Device 1. BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10, 2007. Device Description BioHorizons Tapered Internal Plus Implants are machined titanium, screw…	BioHorizons Implant Systems, Inc.	2007	2

Also cleared against K071638: 11 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K172576	BioHorizons Tapered Short Implants	BioHorizons Implant Systems, Inc.	2017	10
K182070	BioHorizons Tapered IM Implants	BioHorizons Implant Systems, Inc.	2018	0
K150040	Implanova	Dental Evolutions, Inc.	2015	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?

Its one ancestor has a recall.
Of its descendants, K172576 (BioHorizons Implant Systems, Inc., 2017) has gone furthest, with 10 descendants of its own.
11 other devices also cite its predicate K071638.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · DZE

31in 2025

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007high 15 (2016) · low 0 (2011)2026

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

Adverse event reports per year · DZE

465,788in 2025

2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, 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	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

What is it indicated for?

BioHorizons Tapered Internal Plus Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121787 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121787: Biohorizons Tapered Internal Plus Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121787

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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