510(k) · Cleared
ClearedBioHorizons Tapered IM Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BioHorizons Implant Systems, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 10, 2018 as substantially equivalent to K121787 (BioHorizons Implant Systems, Inc., 2012) after a 70-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Oct 10, 2018
- Review
- 70 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071638 (2007). No later device cites it as a predicate yet.
- Root · 2 generations backK071638 Biohorizons Tapered Internal Implant SystemBioHorizons Implant Systems, Inc. · 2007 · Recalled
- 1 generation backK121787 Biohorizons Tapered Internal Plus ImplantsBioHorizons Implant Systems, Inc. · 2012
- This deviceK182070 BioHorizons Tapered IM ImplantsBioHorizons Implant Systems, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071638 | Biohorizons Tapered Internal Implant System | BioHorizons Implant Systems, Inc. | 2007 | 2 |
| −1 | K121787 | Biohorizons Tapered Internal Plus Implants | BioHorizons Implant Systems, Inc. | 2012 | — |
| 0 (this device) | K182070 | BioHorizons Tapered IM Implants | BioHorizons Implant Systems, Inc. | 2018 | — |
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
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 | Decided |
|---|---|---|---|
| * | K121787 | Biohorizons Tapered Internal Plus ImplantsSummary page 4…t Classification Name: Endosseous dental implant Classification Number: Class II (21 CFR 872.3640) Predicate Devices Primary Predicate Device: 1. K121787, BioHorizons Tapered Internal Plus Implants, September 5, 2012. Reference Predicate Devices: 1. K103691, BioHorizons Abutment… | 2012 |
| † | K103691 | Biohorizons Abutments for Zimmer | 2011 |
| † | K151621 | BioHorizons CAD/CAM Abutments | 2016 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K071161 | Endosseous Dental Implant System | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 1 company; a new generation was cleared every 6.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K121787.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 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 IM 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182070: BioHorizons Tapered IM Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182070
Report an extraction error
Are you the manufacturer?
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