510(k) · Cleared
Recalled · Class II · 2016Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare Uas, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 29, 2000 as substantially equivalent to K984104 (Straumann USA, 1999) and 1 other predicate after a 182-day review. Its family tree reaches back 2 generations to 1990. 735 later devices descend from it. It has been recalled once.
- Decided
- Feb 29, 2000
- Review
- 182 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894595 (1990). 9 ancestors in all. 735 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 1 generation backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- This deviceK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000
- Descendant · cites it directly · 568 of its ownK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- Descendant · 2 generations on · 547 of its ownK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- Descendant · 3 generations on · 542 of its ownK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- Descendant · 2 generations on · 425 of its ownK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
- Descendant · 3 generations on · 394 of its ownK032284 Xive TG Dental Implant SystemFriadent GmbH · 2003
Showing 5 of 735 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 735 · See all- K013067Frialoc Dental Implant SystemFriadent GmbH · 2002 · cites it directly568descendants
- K021318Xive Dental Implant SystemFriadent GmbH · 2002 · 2 generations on547descendants
- K032158Xive Dental Implant System MultipleFriadent GmbH · 2003 · 3 generations on542descendants
- K024004Xive Transgingival Dental Implant SystemFriadent GmbH · 2003 · 2 generations on425descendants
- K032284Xive TG Dental Implant SystemFriadent GmbH · 2003 · 3 generations on394descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −1 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| 0 (this device) | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | — |
| +1 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| +2 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| +3 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| +2 | K024004 | Xive Transgingival Dental Implant System | Friadent GmbH | 2003 | — |
| +3 | K032284 | Xive TG Dental Implant System | Friadent GmbH | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 16 | 0 |
| 2008 | 20 | 0 |
| 2009 | 13 | 0 |
| 2010 | 13 | 0 |
| 2011 | 23 | 0 |
| 2012 | 23 | 0 |
| 2013 | 34 | 0 |
| 2014 | 34 | 0 |
| 2015 | 40 | 0 |
| 2016 | 42 | 0 |
| 2017 | 32 | 0 |
| 2018 | 34 | 0 |
| 2019 | 33 | 0 |
| 2020 | 46 | 0 |
| 2021 | 49 | 0 |
| 2022 | 46 | 0 |
| 2023 | 55 | 0 |
| 2024 | 62 | 0 |
| 2025 | 56 | 0 |
| 2026 | 28 | 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? (2)
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 |
|---|---|---|---|
| * | K984104 | Iti Dental Implant SystemSummary page 3…ts For Which Clearance Of An Immediate Load Indication Is Sought Predicate Product Predicate Product Submitted Product Characteristic Straumann ITI Implant (510(k) K984104) Sargon Cylindro-Blade Implant [510(k) K930071] Branemark System® Implant Products** Intended Use intended to be placed in th… | 1999 |
| * | K930071 | Sargon Cylindro-Blade ImplantSummary page 3…ication Is Sought Predicate Product Predicate Product Submitted Product Characteristic Straumann ITI Implant (510(k) K984104) Sargon Cylindro-Blade Implant [510(k) K930071] Branemark System® Implant Products** Intended Use intended to be placed in the maxillary and/or mandibular arches to support… | 1994 |
What descends from it? (735)
See all 7357 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013067 | Frialoc Dental Implant System | 2002 | 568 |
| K030614 | 3I Dental Implants | 2003 | 319 |
| K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 | 305 |
| K041655 | Bio Plant System (Implants and Abutments) | 2004 | 91 |
| K012681 | Ankylos | 2003 | 7 |
| K133255 | Zeramex T and Zeramex Plus Dental Implant Systems | 2014 | 3 |
| K013494 | 3.75MM and 5.0MM Spline Twist Implant | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2016 | Class II | Z-2314-2016 | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K013067 (Friadent GmbH, 2002) has gone furthest, with 568 descendants of its own.
- 9 other devices also cite its predicate K984104.
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?
Selected Branemark System® implant products (those identified in the preceding section, “Device Name”) are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient’s chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. If a single stage surgical procedure is used, these implants may be loaded immediately…
Read the full statement (117 words)
Selected Branemark System® implant products (those identified in the preceding section, “Device Name”) are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient’s chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.
If a single stage surgical procedure is used, these implants may be loaded immediately following insertion - PROVIDED — at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage most often be obtained.
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/K992937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992937: Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992937
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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