510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

MRI compatibility for existing BioHorizons dental implants and abutments

K223697510(k) TraditionalCleared Oct 13, 2023308-day reviewClass II21 CFR 872.3640Recalls 1

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 Oct 13, 2023 after a 308-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.

Decided
Oct 13, 2023
Review
308 days
Class
Class II
Product code
DZE
Recalls
1
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared2020202220242026
  1. This deviceK223697 MRI compatibility for existing BioHorizons dental implants and…BioHorizons Implant Systems, Inc. · 2023
  2. Descendant · cites it directly · 2 of its ownK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
  3. Descendant · 2 generations on · 0 of its ownK260061 BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026
  4. Descendant · 2 generations on · 0 of its ownK243521 Conical Ti Base abutmentsBioHorizons Implant Systems, Inc. · 2025

Most influential descendants

Showing 3 of 3 · See all
  • K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024 · cites it directly2descendants
  • K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026 · 2 generations on0descendants
  • K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K223697MRI compatibility for existing BioHorizons dental implants and abutmentsBioHorizons Implant Systems, Inc.2023—
+1K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.2024—
+2K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.2026—
+2K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202510
202610
FIG. 1 — Lineage of K223697, 2023–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 6, 2024Class IIZ-1111-2025Component design/selectionCertain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K240187 (BioHorizons Implant Systems, Inc., 2024) has gone furthest, with 2 descendants of its own.

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. 2023, this device’s year, is highlighted.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
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

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

BioHorizons implants are intended for use in the mandible or maxilla for use 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. BioHorizons Tapered Short…

Read the full statement (1,001 words)

BioHorizons implants are intended for use in the mandible or maxilla for use 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.

BioHorizons Tapered Short 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 using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures.

BioHorizons Tapered Internal 3.0, Tapered Tissue Level 3.0, and Laser-Lok 3.0 Implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Intra-Lock implants are intended for use in the mandible or maxilla for use 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.

Intra-Lock 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications.

Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

MILO™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function. They are also indicated for the rehabilitation of single maxillary lateral incisors and mandibular lateral and central incisors. The implants may be restored after a period of time or placed in immediate function.

BioHorizons Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.

BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments.

The BioHorizons Multi-unit Abutments for CONELOG® are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on CONELOG dental implants.

BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment. The abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters. All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

Intra-Lock Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with Intra-Lock implants.

Intra-Lock Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments.

Intra-Lock CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment. The abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with Intra-lock implants. All digitally designed abutments and/or copings for use with Intra-Lock CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. Intra-Lock abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

The MILO and Mini Drive Lock Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K223697: MRI compatibility for existing BioHorizons dental implants and abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223697

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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