510(k) Report

510(k) · Cleared

Cleared

Legacy Dental Implants

K073033510(k) TraditionalCleared Dec 10, 200745-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

Implant Direct, LLC · DZE Implant, Endosseous, Root-Form

Cleared on Dec 10, 2007 as substantially equivalent to K013277 (Ivoclar Vivadent, Inc., 2001) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 2001. 25 later devices descend from it.

Decided
Dec 10, 2007
Review
45 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K013277 (2001). 2 ancestors in all. 25 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2009: 1 descendant cleared2016: 2 descendants cleared2013: 3 descendants cleared2018: 2 descendants cleared2017: 1 descendant cleared2020: 3 descendants cleared2025: 3 descendants cleared2021: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2026: 2 descendants cleared2019: 1 descendant cleared2023: 4 descendants clearedK013277 · Astralis 7, Model 557545 · Ivoclar Vivadent, Inc. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 4 descendants K013277 · Astralis 7, Model 557545 · Ivoclar Vivadent, Inc. · 20010+5
  1. Root · 1 generation backK013277 Astralis 7, Model 557545Ivoclar Vivadent, Inc. · 2001
  2. This deviceK073033 Legacy Dental ImplantsImplant Direct, LLC · 2007
  3. Descendant · cites it directly · 22 of its ownK090234 Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
  5. Descendant · 3 generations on · 8 of its ownK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
  6. Descendant · 4 generations on · 6 of its ownK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
  7. Descendant · 5 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2009: 12013: 32015: 12016: 22017: 12018: 22019: 12020: 32021: 12022: 12023: 42025: 32026: 2
2009high 4 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 25 · See all
  • K090234Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · cites it directly22descendants
  • K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · 2 generations on10descendants
  • K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015 · 3 generations on8descendants
  • K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018 · 4 generations on6descendants
  • K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013277Astralis 7, Model 557545Ivoclar Vivadent, Inc.2001—
0 (this device)K073033Legacy Dental ImplantsImplant Direct, LLC2007—
+1K090234Spectra System Dental Implants 2008Implant Direct, LLC200911
+2K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC20134
+3K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC2015—
+4K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC2018—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201330
201510
201620
201710
201820
201910
202030
202110
202210
202340
202530
202620
FIG. 1 — Lineage of K073033, 2001–2026Source: 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
*K013277Astralis 7, Model 557545
Summary page 1
…lant 2. Device Trade Name: Legacy System Dental Implants With HA Coating 3. Predicate Device(s): Zimmer Dental Tapered Screw-Vent Dental Implant System (K01 3277) and Implant Direct's Spectra-System (K061319) 4. Device Description: The Legacy System consists of tapered screw-ty…
Ivoclar Vivadent, Inc.2001—
*K061319Spectra System
Summary page 1
…ental Implants With HA Coating 3. Predicate Device(s): Zimmer Dental Tapered Screw-Vent Dental Implant System (K01 3277) and Implant Direct's Spectra-System (K061319) 4. Device Description: The Legacy System consists of tapered screw-type endosseous implants with the same st…
Implant Direct, LLC20064

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K090234Spectra System Dental Implants 2008Implant Direct, LLC200922
K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180
K153650Microdent Ektos Implant SystemImplants Microdent System S.L20160
K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K090234 (Implant Direct, LLC, 2009) has gone furthest, with 22 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. 2007, 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?

The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

Indications for use as stated in the FDA summary.

More from Implant Direct, LLC

10 FDA decisions under this applicant name. See the company

  • K090234Spectra System Dental Implants 2008Implant Direct, LLC · 200911 recalls
  • K081101Spectra-System Abutments 2008Implant Direct, LLC · 2009
  • K081396Swissplant Dental Implant SystemImplant Direct, LLC · 20093 recalls
  • K080633Screwindirect Dental ImplantsImplant Direct, LLC · 2008
  • K080713Reactive Dental Implant SystemImplant Direct, LLC · 2008

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/K073033 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073033: Legacy Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073033

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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