510(k) Report

510(k) · Cleared

Cleared

The Maestro System

K972313510(k) TraditionalCleared Sep 16, 199788-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 16, 1997 as substantially equivalent to K964330 (BioHorizons Implant Systems, Inc., 1997) after an 88-day review. Its family tree reaches back 2 generations to 1996. 336 later devices descend from it.

Decided
Sep 16, 1997
Review
88 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K960026 (1996). 336 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared2003: 2 descendants cleared2005: 6 descendants cleared2004: 2 descendants cleared2012: 10 descendants cleared2013: 13 descendants cleared2008: 12 descendants cleared2007: 4 descendants cleared2009: 3 descendants cleared2006: 3 descendants cleared2014: 15 descendants cleared2010: 4 descendants cleared2017: 14 descendants cleared2015: 13 descendants cleared2011: 10 descendants cleared2021: 20 descendants cleared2016: 12 descendants cleared2019: 17 descendants cleared2020: 21 descendants cleared2024: 34 descendants cleared2018: 12 descendants cleared2023: 30 descendants cleared2022: 30 descendants cleared2025: 27 descendants cleared2026: 19 descendants clearedK960026 · Biohorizons Dental Implant System · BioHorizons Implant Systems, Inc. · 1996K964330 · Biohorizons Dental Implant System (Name Subject to Change) · BioHorizons Implant Systems, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 27 descendants4 generations forward: 51 descendants5 generations forward: 68 descendants6 generations forward: 63 descendants7 generations forward: 51 descendants8 generations forward: 26 descendants9 generations forward: 13 descendants10 generations forward: 7 descendants11 generations forward: 7 descendants12 generations forward: 6 descendants13 generations forward: 1 descendant14 generations forward: 1 descendant K964330 · Biohorizons Dental Implant System (Name Subject to Change) · BioHorizons Implant Systems, Inc. · 1997K960026 · Biohorizons Dental Implant System · BioHorizons Implant Systems, Inc. · 19960+5+10
  1. Root · 2 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
  2. 1 generation backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
  3. This deviceK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
  4. Descendant · cites it directly · 334 of its ownK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  5. Descendant · cites it directly · 333 of its ownK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  6. Descendant · cites it directly · 332 of its ownK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  7. Descendant · cites it directly · 331 of its ownK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
  8. Descendant · cites it directly · 313 of its ownK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003

Showing 5 of 336 descendants. See all descendants

Descendants cleared per year

2002: 32003: 22004: 22005: 62006: 32007: 42008: 122009: 32010: 42011: 102012: 102013: 132014: 152015: 132016: 122017: 142018: 122019: 172020: 212021: 202022: 302023: 302024: 342025: 272026: 19
2002high 34 (2024) · low 2 (2003)2026

Most influential descendants

Showing 5 of 336 · See all
  • K020133Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002 · cites it directly334descendants
  • K020645Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002 · cites it directly333descendants
  • K022795Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002 · cites it directly332descendants
  • K030463Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · cites it directly331descendants
  • K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003 · cites it directly313descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K960026Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc.1996—
−1K964330Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc.1997—
0 (this device)K972313The Maestro SystemBioHorizons Implant Systems, Inc.1997—
+1K020133Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
+1K020645Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
+1K022795Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
+1K030463Modification to the Maestro SystemBioHorizons Implant Systems, Inc.20031
+1K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200320
200420
200560
200630
200740
2008120
200930
201040
2011100
2012100
2013130
2014150
2015130
2016120
2017140
2018120
2019170
2020210
2021200
2022300
2023300
2024340
2025270
2026190
FIG. 1 — Lineage of K972313, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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. #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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K964330Biohorizons Dental Implant System (Name Subject to Change)
Summary page 3
…lence Information The Maestro System' " is substantially equivalent in all features which could affect safety or effectiveness to the BioHorizons Dental Implant System (K964330) and the Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants. LRVICE M St » 2 Ty SALTY ot ¥ ¢ “, C DEPARTMENT…
BioHorizons Implant Systems, Inc.1997—
*—Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants
Named without a submission number
—

Also cleared against K964330: 5 other devices →

What descends from it? (336)

See all 336

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

NumberDeviceApplicantDecidedDescendants
K020133Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002334
K020645Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002333
K022795Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002332
K030463Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2003331
K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc.2003313
K042971Titan Dental Implant SystemTitan Implants, Inc.20050

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 1 year and passes through 1 company; a new generation was cleared every 10 months on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K020133 (BioHorizons Implant Systems, Inc., 2002) has gone furthest, with 334 descendants of its own.
  • 5 other devices also cite its predicate K964330.

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.

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?

The BioHorizons Maestro System™ is indicated for use as an artificial root structure for

single tooth replacement or as abutments for bridgework and denture retention in the

mandible and maxilla.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K964330

5 other devices cite the same predicate.

  • K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
  • K030463Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 20031 recall
  • K022795Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  • K020645Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  • K020133Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002

More from BioHorizons Implant Systems, Inc.

41 FDA decisions under this applicant name. See the company

  • K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026
  • K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc. · 2025
  • K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentBioHorizons Implant Systems, Inc. · 2024
  • K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
  • K223697MRI compatibility for existing BioHorizons dental implants and abutmentsBioHorizons Implant Systems, Inc. · 20231 recall

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K972313 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972313: The Maestro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972313

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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