510(k) · Cleared
ClearedBLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Mar 8, 2017 as substantially equivalent to K140878 (Straumann USA, LLC, 2014) and 8 other predicates after a 142-day review. Its family tree reaches back 15 generations to 1990. 5 later devices descend from it.
- Decided
- Mar 8, 2017
- Review
- 142 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 15 generations to K894844 (1990). 261 ancestors in all, the oldest K781060 (1978). 5 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 11 generations between
- 3 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 2 generations backK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- 1 generation backK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- This deviceK162890 BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and…Straumann USA, LLC · 2017
- Descendant · cites it directly · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK192893 Straumann Ceramic Healing AbutmentsInstitut Straumann AG · 2020
- Descendant · 2 generations on · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK232383 iPhysio® SystemEuroteknika · 2025
- Descendant · cites it directly · 0 of its ownK173945 Straumann SC Variobase AbutmentsInstitut Straumann AG · 2018
Show all 15 generations
- Root · 15 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 14 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 13 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 12 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 11 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 10 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 9 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 8 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 7 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 6 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 5 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 4 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 3 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 2 generations backK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- 1 generation backK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- This deviceK162890 BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and…Straumann USA, LLC · 2017
Most influential descendants
Showing 5 of 5 · See all- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · cites it directly1descendant
- K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG · 2020 · cites it directly1descendant
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · 2 generations on0descendants
- K232383iPhysio® SystemEuroteknika · 2025 · 2 generations on0descendants
- K173945Straumann SC Variobase AbutmentsInstitut Straumann AG · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −14 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −13 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −12 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −11 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −10 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −9 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −8 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −7 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −6 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −5 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −4 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −3 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −2 | K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM)… | Straumann USA, LLC | 2014 | — |
| −1 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| 0 (this device) | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing… | Straumann USA, LLC | 2017 | — |
| +1 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +1 | K192893 | Straumann Ceramic Healing Abutments | Institut Straumann AG | 2020 | — |
| +2 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
| +2 | K232383 | iPhysio® System | Euroteknika | 2025 | — |
| +1 | K173945 | Straumann SC Variobase Abutments | Institut Straumann AG | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 12 | 0 |
| 1996 | 16 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 12 | 0 |
| 2006 | 13 | 0 |
| 2007 | 17 | 0 |
| 2008 | 11 | 0 |
| 2009 | 9 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K140878 | Straumann Bone Level Tapered ImplantSummary page 5…: §872.3640 Classification: Class II Product Codes: DZE, NHA 5.3 Predicate Device(s) Primary Predicate: K140878 – Straumann Bone Level Tapered Implant Straumann USA, LLC March 6, 2017 5-1 =… | 2014 |
| * | K120414 | Osseospeed PlusSummary page 6…Traditional 510(k) Submission Straumann® Ø2.9 mm Bone Level Tapered Implants 510(k) Summary Reference Devices: K120414 – OsseoSpeed™ Plus K130808 – Straumann Healing Abutments, Healing Caps, and Closure Screws K092814 – Straumann NC Temporary Abutm… | 2012 |
| * | K130808 | Straumann Healing Abutments, Healing Caps, Closure ScrewsSummary page 6…ission Straumann® Ø2.9 mm Bone Level Tapered Implants 510(k) Summary Reference Devices: K120414 – OsseoSpeed™ Plus K130808 – Straumann Healing Abutments, Healing Caps, and Closure Screws K092814 – Straumann NC Temporary Abutments K120822 – Straumann C… | 2013 |
| * | K092814 | Straumann Dental AbutmentsSummary page 6…510(k) Summary Reference Devices: K120414 – OsseoSpeed™ Plus K130808 – Straumann Healing Abutments, Healing Caps, and Closure Screws K092814 – Straumann NC Temporary Abutments K120822 – Straumann CARES Variobase Abutments K142890 – Straumann Variobase Abutments K1502… | 2009 |
| * | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Summary page 6…mmary Reference Devices: K120414 – OsseoSpeed™ Plus K130808 – Straumann Healing Abutments, Healing Caps, and Closure Screws K092814 – Straumann NC Temporary Abutments K120822 – Straumann CARES Variobase Abutments K142890 – Straumann Variobase Abutments K150203 – Medentika CAD/CAM Abutments K150899 – S… | 2012 |
| * | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Summary page 6…™ Plus K130808 – Straumann Healing Abutments, Healing Caps, and Closure Screws K092814 – Straumann NC Temporary Abutments K120822 – Straumann CARES Variobase Abutments K142890 – Straumann Variobase Abutments K150203 – Medentika CAD/CAM Abutments K150899 – Straumann CARES TAN Abutments K062129 – P.004 I… | 2015 |
| * | K150203 | Medentika CAD/CAM AbutmentsSummary page 6…nts, Healing Caps, and Closure Screws K092814 – Straumann NC Temporary Abutments K120822 – Straumann CARES Variobase Abutments K142890 – Straumann Variobase Abutments K150203 – Medentika CAD/CAM Abutments K150899 – Straumann CARES TAN Abutments K062129 – P.004 Implants 5.4 Device Description The… | 2015 |
| * | K150899 | Straumann CARES Titanium Alloy (TAN) AbutmentSummary page 6…K092814 – Straumann NC Temporary Abutments K120822 – Straumann CARES Variobase Abutments K142890 – Straumann Variobase Abutments K150203 – Medentika CAD/CAM Abutments K150899 – Straumann CARES TAN Abutments K062129 – P.004 Implants 5.4 Device Description The Straumann Ø2.9mm Bone Level Tapered (… | 2015 |
| * | K062129 | P.0004 ImplantsSummary page 6…s K120822 – Straumann CARES Variobase Abutments K142890 – Straumann Variobase Abutments K150203 – Medentika CAD/CAM Abutments K150899 – Straumann CARES TAN Abutments K062129 – P.004 Implants 5.4 Device Description The Straumann Ø2.9mm Bone Level Tapered (BLT) Implants are apically tapered implan… | 2006 |
What descends from it? (5)
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)
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 27 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 27 of the 261 ancestors have a recall of any class.
- Of its descendants, K231395 (Cowellmedi Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K140878.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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® Bone Level Tapered Implants ∅2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants ∅2.9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth or multiple-tooth applications when…
Read the full statement (347 words)
Straumann® Bone Level Tapered Implants ∅2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants ∅2.9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth or multiple-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 components (abutments).
The Straumann® Bone Level Tapered Implants ∅2.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient’s jaw to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection.
Straumann® SC Temporary Abutments are indicated 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. Straumann® SC Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. 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.
Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
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/K162890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162890: BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162890
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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