510(k) · Cleared
ClearedStraumann BLX Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · DZE Implant, Endosseous, Root-Form
Cleared on Jun 5, 2018 as substantially equivalent to K150182 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2015) after a 159-day review. Its family tree reaches back 15 generations to 1996. 15 later devices descend from it.
- Decided
- Jun 5, 2018
- Review
- 159 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K960026 (1996). 120 ancestors in all, the oldest K874590 (1988). 15 later devices descend from it, 5 citing it directly.
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations between
- 3 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 2 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 1 generation backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- This deviceK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- Descendant · cites it directly · 5 of its ownK181703 Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG · 2018
- Descendant · cites it directly · 4 of its ownK200586 Straumann TLX Implant SystemInstitut Straumann AG · 2020
- Descendant · 2 generations on · 2 of its ownK192401 Straumann Screw-Retained AbutmentsStraumann USA, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK221315 UNIdental Symphony Implant SystemUnidental Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK220751 Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG · 2022
Show all 15 generations
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 13 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 12 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 8 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 7 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 6 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 5 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 4 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 3 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 2 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 1 generation backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- This deviceK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG · 2018 · cites it directly5descendants
- K200586Straumann TLX Implant SystemInstitut Straumann AG · 2020 · cites it directly4descendants
- K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC · 2020 · 2 generations on2descendants
- K221315UNIdental Symphony Implant SystemUnidental Co., Ltd. · 2023 · 2 generations on1descendant
- K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −14 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −8 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −7 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −6 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −5 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −4 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −3 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −2 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −1 | K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| 0 (this device) | K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018 | — |
| +1 | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | Institut Straumann AG | 2018 | — |
| +1 | K200586 | Straumann TLX Implant System | Institut Straumann AG | 2020 | — |
| +2 | K192401 | Straumann Screw-Retained Abutments | Straumann USA, LLC | 2020 | — |
| +2 | K221315 | UNIdental Symphony Implant System | Unidental Co., Ltd. | 2023 | — |
| +1 | K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | Institut Straumann AG | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 12 | 0 |
| 2002 | 14 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K150182 | Neodent Implant System- CM Drive ImplantsSummary page 5…II Product Codes: Primary product code: DZE Secondary product code: NHA 5.3 Predicate Device(s) Primary Predicate: • K150182 – Neodent Implant System – CM Drive Implants Reference Devices: • K122855 TL 04.1mm RN,S, SLAcitve TiZr 6, 8, 10, 12,… | 2015 |
| † | K122855 | TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants | 2012 |
| † | K033922 | Modification to Iti Dental Implant System | 2004 |
| † | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC… | 2017 |
| † | K101545 | Genesis Implant System | 2010 |
| † | K153624 | Neodent Implant System | 2016 |
| † | K170838 | Medentika CAD/CAM TiBases | 2017 |
| † | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | 2013 |
| † | K092814 | Straumann Dental Abutments | 2009 |
| † | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann… | 2012 |
| † | K170354 | Straumann Variobase Abutments | 2017 |
| † | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase… | 2015 |
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | 2018 | 5 |
| K200586 | Straumann TLX Implant System | 2020 | 4 |
| K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | 2022 | 1 |
| K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech… | 2024 | 0 |
| K200597 | Straumann BLX Gold Abutments | 2020 | 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 22 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 13 of the 120 ancestors have a recall of any class.
- Of its descendants, K181703 (Institut Straumann AG, 2018) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K150182.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the…
Read the full statement (328 words)
Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient’s mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated.
BLX Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173961: Straumann BLX 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/K173961
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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