510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Swissplant Dental Implant System

K081396510(k) TraditionalCleared Jan 14, 2009240-day reviewClass II21 CFR 872.3630Recalls 3

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

Implant Direct, LLC · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jan 14, 2009 as substantially equivalent to K011245 (Sulzer Dental, Inc., 2001) after a 240-day review. Its family tree reaches back 1 generation to 2001. 13 later devices descend from it. It has been recalled 3 times.

Decided
Jan 14, 2009
Review
240 days
Class
Class II
Product code
NHA
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K011245 (2001). 13 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2012: 1 descendant cleared2021: 1 descendant cleared2016: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2023: 4 descendants clearedK011245 · Advent Implant System, Swiss Plus Implant System · Sulzer Dental, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 4 descendants K011245 · Advent Implant System, Swiss Plus Implant System · Sulzer Dental, Inc. · 20010+5
  1. Root · 1 generation backK011245 Advent Implant System, Swiss Plus Implant SystemSulzer Dental, Inc. · 2001
  2. This deviceK081396 Swissplant Dental Implant SystemImplant Direct, LLC · 2009
  3. Descendant · cites it directly · 10 of its ownK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
  4. Descendant · 2 generations on · 8 of its ownK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
  5. Descendant · 3 generations on · 6 of its ownK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
  6. Descendant · 4 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
  7. Descendant · 4 generations on · 1 of its ownK191458 Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22015: 12016: 12018: 12019: 12020: 12021: 12023: 4
2012high 4 (2023) · low 0 (2014)2026

Most influential descendants

Showing 5 of 13 · See all
  • K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · cites it directly10descendants
  • K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015 · 2 generations on8descendants
  • K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018 · 3 generations on6descendants
  • K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 4 generations on3descendants
  • K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011245Advent Implant System, Swiss Plus Implant SystemSulzer Dental, Inc.2001—
0 (this device)K081396Swissplant Dental Implant SystemImplant Direct, LLC2009—
+1K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC20134
+2K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC2015—
+3K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC2018—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.2020—
+4K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201510
201610
201810
201910
202010
202110
202340
FIG. 1 — Lineage of K081396, 2001–2023Source: 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 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 NHA? 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 NHA device

  1. #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K011245Advent Implant System, Swiss Plus Implant SystemSulzer Dental, Inc.2001—

Also cleared against K011245: 5 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.

NumberDeviceApplicantDecidedDescendants
K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC201310
K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130
K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 9, 2019Class IIZ-1126-2020Process controlDue to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered…
Jan 19, 2018Class IIZ-1168-2018Process controlThe extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Oct 28, 2015Class IIZ-0396-2016Unknown/Undetermined by firmImplant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K130572 (Implant Direct Sybron Manufacturing, LLC, 2013) has gone furthest, with 10 descendants of its own.
  • 5 other devices also cite its predicate K011245.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

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

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

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

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

What is it indicated for?

The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.

Indications for use as stated in the FDA summary.

Also cleared against K011245

5 other devices cite the same predicate.

  • K083670Universal, Aesthetica, Natea, NaturaEuroteknika · 2009
  • K083669OBIEuroteknika · 2009
  • K073049Screwplus Dental Implants (HA)Implant Direct, LLC · 2007
  • K063106Revois Implant SystemCurasan AG · 2007
  • K061410Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer…Zimmer Dental, Inc. · 20061 recall

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
  • K080633Screwindirect Dental ImplantsImplant Direct, LLC · 2008
  • K080713Reactive Dental Implant SystemImplant Direct, LLC · 2008
  • K073161Replus Dental Implants (HA)Implant Direct, LLC · 2008

Recent decisions in NHA

The NHA category page

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  • K262207Cemented Plus AbutmentUnidental Co., Ltd. · 2026
  • K260940BellaTek BarsZimVie US Corp, LLC · 2026
  • K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment…Nobel Biocare AB · 2026
  • K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026

https://510kreport.com/device/K081396 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081396: Swissplant Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081396

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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