510(k) · Cleared
ClearedSpectra-System Abutments 2008
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Direct, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 14, 2009 as substantially equivalent to K061319 (Implant Direct, LLC, 2006) and 2 other predicates after a 272-day review. Its family tree reaches back 6 generations to 1990. 11 later devices descend from it.
- Decided
- Jan 14, 2009
- Review
- 272 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K894595 (1990). 21 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 4 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 3 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 2 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 1 generation backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- This deviceK081101 Spectra-System Abutments 2008Implant Direct, LLC · 2009
- Descendant · cites it directly · 10 of its ownK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
- Descendant · 2 generations on · 8 of its ownK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
- Descendant · 3 generations on · 6 of its ownK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
- Descendant · 4 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · 4 generations on · 1 of its ownK191458 Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −5 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −4 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −3 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −2 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| 0 (this device) | K081101 | Spectra-System Abutments 2008 | Implant Direct, LLC | 2009 | — |
| +1 | K130572 | Interactive/ SWISHPLUS2 Implant System | Implant Direct Sybron Manufacturing, LLC | 2013 | 4 |
| +2 | K143011 | 2014 InterActive/SwishActive System | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| +3 | K181359 | InterActive SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | 2018 | — |
| +4 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +4 | K191458 | Legacy SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | 2019 | — |
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 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 30.6 · 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? (3)
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 |
|---|---|---|---|
| * | K061319 | Spectra System | 2006 |
| * | K011028 | Screw-Vent Dental Implant System | 2001 |
| * | K050258 | Groovy ImplantsSummary page 1…(KO6131 9), Sulzer Dental Screw-Vent Dental Implant System Custom Cast Abutments (KOI 1028), Nobel Replace Tapered Groovy Custom Cast Abutments (K050258), Nobel Replace Tapered Groovy Multi Unit Abutments (K050258) 4. Device Description: Spectra-System Abutments 2008 co… | 2005 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130572 | Interactive/ SWISHPLUS2 Implant System | 2013 | 10 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K130572 (Implant Direct Sybron Manufacturing, LLC, 2013) has gone furthest, with 10 descendants of its own.
- 15 other devices also cite its predicate K061319.
How does its category compare?
All NHA devicesNHA 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
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?
Spectra-System Abutments are designed to be used in support of a dental
implant(s) to provide support for prosthetic restorations such as crowns, bridges,
overdentures or custom prosthetic fabrications in a partially or completely
edentulous patient. Spectra-System Abutments are intended for use in the
mandible or maxilla. Prostheses can be screw or cement retained to the
abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081101 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081101: Spectra-System Abutments 2008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081101
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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