510(k) · Cleared
ClearedLegacy SMARTBase Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Direct Sybron Manufacturing, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 10, 2019 as substantially equivalent to K181359 (Implant Direct Sybron Manufacturing, LLC, 2018) after a 132-day review. Its family tree reaches back 12 generations to 1990. 1 later device descends from it.
- Decided
- Oct 10, 2019
- Review
- 132 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 43 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
- 2 generations backK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
- 1 generation backK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
- This deviceK191458 Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019
- Descendant · cites it directly · 0 of its ownK223535 SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC · 2023 · Recalled
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 4 generations backK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- 3 generations backK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
- 2 generations backK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
- 1 generation backK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
- This deviceK191458 Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −4 | K102436 | Nobel Active 3.0 | Nobel Biocare AB | 2010 | — |
| −3 | K130572 | Interactive/ SWISHPLUS2 Implant System | Implant Direct Sybron Manufacturing, LLC | 2013 | 4 |
| −2 | K143011 | 2014 InterActive/SwishActive System | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −1 | K181359 | InterActive SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | 2018 | — |
| 0 (this device) | K191458 | Legacy SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | 2019 | — |
| +1 | K223535 | SMARTbase Abutment System | Implant Direct Sybron Manufacturing, LLC | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K181359 | InterActive SMARTBase AbutmentsSummary page 4…Primary Product Code: NHA Secondary Product Code: PNP Primary Predicate: Implant Direct Sybron Manufacturing, LLC’s InterActive SMARTBase Abutments (K181359) Reference Devices: Implant Direct Sybron Manufacturing, LLC’s Spectra-System Dental Implants 2008 (K090234); 3… | 2018 |
| † | K090234 | Spectra System Dental Implants 2008 | 2009 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223535 | SMARTbase Abutment System | 2023 | 0 |
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 29 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 43 ancestors have a recall of any class.
- Of its descendants, K223535 (Implant Direct Sybron Manufacturing, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181359.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations. The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral…
Read the full statement (211 words)
The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.
The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTBase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment.
x Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
x Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.
Compatibility
Legacy SMARTBase engaging abutments are compatible at the implant level with Legacy (3.0mm, 3.5mm, 4.5mm and 5.7mm platform diameter) implants, excluding 6mm length implants.
Implant Line Body Diameter Platform Diameter Implant Length
Legacy1 3.7mm, 4.2mm, 4.7mm, 5.7mm 3.5mm, 4.5mm, 8mm, 10mm,
5.7mm 11.5mm, 13mm,
Legacy2, 3, 4, simplyLegacy2, 3.2mm, 3.7mm, 4.2mm, 4.7mm, 3.0mm, 3.5mm, 16mm
simplyLegacy3 5.2mm, 5.7mm, 7.0mm 4.5mm, 5.7mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191458: Legacy SMARTBase Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191458
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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