510(k) · Cleared
Recalled · Class II · 2018Interactive/ SWISHPLUS2 Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Direct Sybron Manufacturing, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Dec 24, 2013 as substantially equivalent to K102436 (Nobel Biocare AB, 2010) and 8 other predicates after a 295-day review. Its family tree reaches back 9 generations to 1990. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 24, 2013
- Review
- 295 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 4
- Predicates
- 9
Its longest line of descent runs back 9 generations to K894595 (1990). 40 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- This deviceK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013
- Descendant · cites it directly · 8 of its ownK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
- Descendant · 2 generations on · 6 of its ownK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
- Descendant · 3 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK191458 Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019
- Descendant · 4 generations on · 0 of its ownK230873 Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- This deviceK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015 · cites it directly8descendants
- K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018 · 2 generations on6descendants
- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 3 generations on3descendants
- K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019 · 3 generations on1descendant
- K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −1 | K102436 | Nobel Active 3.0 | Nobel Biocare AB | 2010 | — |
| 0 (this device) | K130572 | Interactive/ SWISHPLUS2 Implant System | Implant Direct Sybron Manufacturing, LLC | 2013 | — |
| +1 | K143011 | 2014 InterActive/SwishActive System | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| +2 | K181359 | InterActive SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | 2018 | — |
| +3 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +3 | K191458 | Legacy SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | 2019 | — |
| +4 | K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Southern Implants (Pty), Ltd. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K102436 | Nobel Active 3.0Summary page 1…Regulation Number: 872.3630 and 872.3640 Product Codes: OZE and NHA Regulatory Class: 11 3. Predicate Device(s): NobelActive 3.0 (K1 02436) NobelActive Internal Connection Implants (K071370) Spectra-System Dental Implants 2008 (K090234) Spec… | 2010 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 1…ct Codes: OZE and NHA Regulatory Class: 11 3. Predicate Device(s): NobelActive 3.0 (K1 02436) NobelActive Internal Connection Implants (K071370) Spectra-System Dental Implants 2008 (K090234) Spectra-System Abutments 2008 (K081 101) SwissPlant Den… | 2007 |
| * | K090234 | Spectra System Dental Implants 2008Summary page 1…Predicate Device(s): NobelActive 3.0 (K1 02436) NobelActive Internal Connection Implants (K071370) Spectra-System Dental Implants 2008 (K090234) Spectra-System Abutments 2008 (K081 101) SwissPlant Dental Implant System (K081396) Spectra-System (K… | 2009 |
| * | K081101 | Spectra-System Abutments 2008Summary page 1…3.0 (K1 02436) NobelActive Internal Connection Implants (K071370) Spectra-System Dental Implants 2008 (K090234) Spectra-System Abutments 2008 (K081 101) SwissPlant Dental Implant System (K081396) Spectra-System (K061 319), Bicon Implants with a 2.5mm Int… | 2009 |
| * | K081396 | Swissplant Dental Implant SystemSummary page 1…on Implants (K071370) Spectra-System Dental Implants 2008 (K090234) Spectra-System Abutments 2008 (K081 101) SwissPlant Dental Implant System (K081396) Spectra-System (K061 319), Bicon Implants with a 2.5mm Internal Connection (K092035) Bicon 5.0x5.Omm… | 2009 |
| * | K061319 | Spectra SystemSummary page 1…ctra-System Dental Implants 2008 (K090234) Spectra-System Abutments 2008 (K081 101) SwissPlant Dental Implant System (K081396) Spectra-System (K061 319), Bicon Implants with a 2.5mm Internal Connection (K092035) Bicon 5.0x5.Omm Dental Implant and 6.0x5.0 Dental I… | 2006 |
| * | K092035 | Bicon Implants with a 2.5MM Internal ConnectionSummary page 1…utments 2008 (K081 101) SwissPlant Dental Implant System (K081396) Spectra-System (K061 319), Bicon Implants with a 2.5mm Internal Connection (K092035) Bicon 5.0x5.Omm Dental Implant and 6.0x5.0 Dental Implant (K073368) Straumann ITI Dental Implant System (K0300… | 2009 |
| * | K073368 | 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental ImplantSummary page 1…Spectra-System (K061 319), Bicon Implants with a 2.5mm Internal Connection (K092035) Bicon 5.0x5.Omm Dental Implant and 6.0x5.0 Dental Implant (K073368) Straumann ITI Dental Implant System (K030007) 4. Device Description: The lnterActive/SwishPlus2 Implan… | 2008 |
| * | K030007 | Iti Dental Implant SystemSummary page 1…nts with a 2.5mm Internal Connection (K092035) Bicon 5.0x5.Omm Dental Implant and 6.0x5.0 Dental Implant (K073368) Straumann ITI Dental Implant System (K030007) 4. Device Description: The lnterActive/SwishPlus2 Implant System consists of InterActive implant, Swis… | 2003 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2018 | Class II | Z-0363-2020 | Packaging | packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit. |
| Mar 14, 2018 | Class II | Z-1917-2018 | Labeling mix-ups | The cap on the vial might be labeled with the incorrect part number but the main vial label is correct. |
| Jan 23, 2018 | Class II | Z-0539-2018 | Process control | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized. |
| Mar 3, 2017 | Class II | Z-2551-2018 | Process control | The main vial label lists the incorrect part number, but the cap label is correct. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 11 of the 40 ancestors have a recall of any class.
- Of its descendants, K143011 (Implant Direct Sybron Manufacturing, LLC, 2015) has gone furthest, with 8 descendants of its own.
- 13 other devices also cite its predicate K102436.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
lnterActive/SwishPlus2 Implant System consists of twa-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal…
Read the full statement (157 words)
lnterActive/SwishPlus2 Implant System consists of twa-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Narrow Diameter (3.2, 3.3mm) 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.
Compatibility: InterActive and SwishPlus2 implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobeLActive NP (Narrow Platform - 3.0mm diameter) and NobelActiveml RP (Regular Platform - 3.4mm diameter) abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection.NobelActive M NP (Narrow Platform- 3.0mm diameter) and Nobe[Active h RP (Regular Platform - 3.4mm diameter) (3.5-5.OmmD, 8.5-1 SmmLength) implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130572: Interactive/ SWISHPLUS2 Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130572
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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