510(k) · Cleared
ClearedNobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)
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 Jan 28, 2000 as substantially equivalent to K930071 (Sargon Ent., Inc., 1994) and 1 other predicate after a 95-day review. Its family tree reaches back 2 generations to 1990. 942 later devices descend from it.
- Decided
- Jan 28, 2000
- Review
- 95 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894595 (1990). 9 ancestors in all. 942 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 deviceK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- Descendant · cites it directly · 689 of its ownK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- Descendant · 3 generations on · 532 of its ownK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
- Descendant · 3 generations on · 511 of its ownK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- Descendant · 4 generations on · 507 of its ownK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
Showing 5 of 942 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 942 · See all- K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · cites it directly689descendants
- K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · 2 generations on622descendants
- K050705Tiunite ImplantsNobel Biocare AB · 2005 · 3 generations on532descendants
- K050258Groovy ImplantsNobel Biocare AB · 2005 · 3 generations on511descendants
- K061003SFB & CFB ImplantsNobel Biocare AB · 2006 · 4 generations on507descendants
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) | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| +1 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| +2 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| +3 | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | 1 |
| +3 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| +4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
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 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 9 | 0 |
| 2006 | 18 | 0 |
| 2007 | 16 | 0 |
| 2008 | 29 | 0 |
| 2009 | 26 | 0 |
| 2010 | 24 | 0 |
| 2011 | 33 | 0 |
| 2012 | 34 | 0 |
| 2013 | 51 | 0 |
| 2014 | 43 | 0 |
| 2015 | 45 | 0 |
| 2016 | 48 | 0 |
| 2017 | 47 | 0 |
| 2018 | 44 | 0 |
| 2019 | 37 | 0 |
| 2020 | 72 | 0 |
| 2021 | 54 | 0 |
| 2022 | 57 | 0 |
| 2023 | 74 | 0 |
| 2024 | 76 | 0 |
| 2025 | 64 | 0 |
| 2026 | 32 | 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 |
|---|---|---|---|
| * | K930071 | Sargon Cylindro-Blade ImplantSummary page 3…he Submitted Device, Nobel Biocare's Modified Surface Implant Implant 510(k) # Product (and Manufacturer) Modified Surface Implant | K # pending Cylindro-Blade Implant K930071 (Sargon) ITI “One Part” Implant K984104 (Straumann) Page 3 of 4 Nobel Biocare USA, Inc. 510(k) Notification: Mo… | 1994 |
| * | K984104 | Iti Dental Implant SystemSummary page 3…ified Surface Implant Implant 510(k) # Product (and Manufacturer) Modified Surface Implant | K # pending Cylindro-Blade Implant K930071 (Sargon) ITI “One Part” Implant K984104 (Straumann) Page 3 of 4 Nobel Biocare USA, Inc. 510(k) Notification: Modified Surface Implant (Immediate Loadin… | 1999 |
What descends from it? (942)
See all 9427 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023113 | Replace Tiunite Endosseous Implant | 2002 | 689 |
| K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 | 305 |
| K011879 | 3A Dental Implant System | 2002 | 223 |
| K041655 | Bio Plant System (Implants and Abutments) | 2004 | 91 |
| K052369 | Exfeel Implant System | 2006 | 84 |
| K052254 | Mytis Arrow XXXX | 2006 | 0 |
| K013494 | 3.75MM and 5.0MM Spline Twist Implant | 2002 | 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 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, K023113 (Nobel Biocare Uas, Inc., 2002) has gone furthest, with 689 descendants of its own.
- 4 other devices also cite its predicate K930071.
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?
Nobel Biocare's Modified Surface Implant is 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 the single stage 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 predominarttly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can 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/K993595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993595
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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