510(k) · Cleared
Recalled · Class II · 2023SMARTbase Abutment System
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 Jun 20, 2023 as substantially equivalent to K191458 (Implant Direct Sybron Manufacturing, LLC, 2019) after a 209-day review. Its family tree reaches back 13 generations to 1990. It has been recalled once.
- Decided
- Jun 20, 2023
- Review
- 209 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 13 generations to K894595 (1990). 44 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
- 2 generations backK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
- 1 generation backK191458 Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019
- This deviceK223535 SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC · 2023
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 9 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 8 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 7 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 6 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 5 generations backK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- 4 generations backK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
- 3 generations backK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
- 2 generations backK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
- 1 generation backK191458 Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019
- This deviceK223535 SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −9 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −8 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −7 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −6 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −5 | K102436 | Nobel Active 3.0 | Nobel Biocare AB | 2010 | — |
| −4 | K130572 | Interactive/ SWISHPLUS2 Implant System | Implant Direct Sybron Manufacturing, LLC | 2013 | 4 |
| −3 | K143011 | 2014 InterActive/SwishActive System | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −2 | K181359 | InterActive SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | 2018 | — |
| −1 | K191458 | Legacy SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | 2019 | — |
| 0 (this device) | K223535 | SMARTbase Abutment System | Implant Direct Sybron Manufacturing, LLC | 2023 | — |
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 |
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 30.7 · 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 |
|---|---|---|---|
| * | K191458 | Legacy SMARTBase AbutmentsSummary page 4…II Product Code: NHA (Primary), PNP (Secondary) iii. Predicate Devices Primary Predicate Device Propriety Name: LegacyTM SMARTBase Abutments (K191458) Manufacturer: Implant Direct Sybron Manufacturing LLC Common Name: Dental Abutment Classification Name:… | 2019 |
| † | K181359 | InterActive SMARTBase Abutments | 2018 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K061319 | Spectra System | 2006 |
| † | K081101 | Spectra-System Abutments 2008 | 2009 |
| † | K193352 | AbutmentCAD | 2021 |
| † | K222288 | DESS Dental Smart Solutions | 2022 |
| † | K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2023 | Class II | Z-2037-2023 | No Marketing Application | Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 44 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations. The 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 (184 words)
The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations.
The 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 SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment.
• SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
• SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.
• SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223535: SMARTbase Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223535
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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