510(k) · Cleared
ClearedStraumann Dental 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 30, 2004 as substantially equivalent to K971578 (Straumann USA, 1997) and 9 other predicates after a 190-day review. Its family tree reaches back 6 generations to 1990. 376 later devices descend from it.
- Decided
- Jun 30, 2004
- Review
- 190 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 6 generations to K894595 (1990). 34 ancestors in all, the oldest K894844 (1990). 376 later devices descend from it, 15 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 backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 3 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 1 generation backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- This deviceK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- Descendant · cites it directly · 295 of its ownK053088 Slactive ImplantsInstitut Straumann AG · 2006
- Descendant · 2 generations on · 228 of its ownK083550 Straumann Dental Implant SystemStraumann USA · 2009
- Descendant · 2 generations on · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- Descendant · 3 generations on · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- Descendant · cites it directly · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
Showing 5 of 376 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 376 · See all- K053088Slactive ImplantsInstitut Straumann AG · 2006 · cites it directly295descendants
- K083550Straumann Dental Implant SystemStraumann USA · 2009 · 2 generations on228descendants
- K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · 2 generations on228descendants
- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · 3 generations on222descendants
- K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · cites it directly187descendants
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 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −3 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −1 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| 0 (this device) | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| +1 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| +2 | K083550 | Straumann Dental Implant System | Straumann USA | 2009 | — |
| +2 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| +3 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| +1 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 12 | 0 |
| 2013 | 14 | 0 |
| 2014 | 15 | 0 |
| 2015 | 21 | 0 |
| 2016 | 14 | 0 |
| 2017 | 17 | 0 |
| 2018 | 21 | 0 |
| 2019 | 18 | 0 |
| 2020 | 27 | 0 |
| 2021 | 30 | 0 |
| 2022 | 31 | 0 |
| 2023 | 36 | 0 |
| 2024 | 41 | 0 |
| 2025 | 32 | 0 |
| 2026 | 21 | 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? (10)
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 |
|---|---|---|---|
| * | K971578 | Endosseous Dental ImplantSummary page 1…Endosseous Dental Implant (21 CFR 872.3640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4.… | 1997 |
| * | K983742 | Iti Dental Implant SystemSummary page 1…eous Dental Implant (21 CFR 872.3640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4. Descr… | 1999 |
| * | K984104 | Iti Dental Implant SystemSummary page 1…al Implant (21 CFR 872.3640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4. Description of… | 1999 |
| * | K003271 | Modification to Iti Dental Implant SystemSummary page 1…t (21 CFR 872.3640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4. Description of the Devi… | 2001 |
| * | K010291 | Iti Dental Implant SystemSummary page 1…872.3640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4. Description of the Device… | 2001 |
| * | K012757 | Iti Dental Implant SystemSummary page 1…Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4. Description of the Device The Straumann so… | 2001 |
| * | K030007 | Iti Dental Implant SystemSummary page 1…rketed Devices to which Equivalence is Claimed (Predicate Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4. Description of the Device The Straumann solid screw de… | 2003 |
| * | K031674 | Modification to Frialit-2 Dental Implant SystemSummary page 1…med (Predicate Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4. Description of the Device The Straumann solid screw dental implants are of various diameters and… | 2003 |
| * | K032158 | Xive Dental Implant System MultipleSummary page 1…icate Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4. Description of the Device The Straumann solid screw dental implants are of various diameters and lengths… | 2003 |
| * | K032284 | Xive TG Dental Implant SystemSummary page 1…Devices) Ti Dental Implant System (K971578, K983742, K984104, K003271, K010291, K01 2757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284) 4. Description of the Device The Straumann solid screw dental implants are of various diameters and lengths with… | 2003 |
What descends from it? (376)
See all 37615 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053088 | Slactive Implants | 2006 | 295 |
| K063364 | Alpha Bio Dental Implant System | 2007 | 187 |
| K122855 | TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants | 2012 | 123 |
| K123784 | Straumann Dental Implant System | 2013 | 122 |
| K130222 | Straumann Dental Implant System | 2013 | 118 |
| K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua… | 2014 | 109 |
| K112787 | Kerator | 2012 | 3 |
| K040757 | Sic Pro | 2005 | 2 |
| K093615 | Spi Dental Implant, Element | 2010 | 1 |
| K072425 | Jne Implant System | 2008 | 1 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 34 ancestors have a recall of any class.
- Of its descendants, K053088 (Institut Straumann AG, 2006) has gone furthest, with 295 descendants of its own.
- 6 other devices also cite its predicate K971578.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033984: Straumann Dental 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/K033984
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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