510(k) · Cleared
ClearedThe Guided Surgery Concept
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · DZE Implant, Endosseous, Root-Form
Cleared on May 4, 2005 as substantially equivalent to K030685 (Nobel Biocare AB, 2004) after a 77-day review. Its family tree reaches back 2 generations to 2000. 258 later devices descend from it.
- Decided
- May 4, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000018 (2000). 3 ancestors in all. 258 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK000018 Branemark NovumNobel Biocare Uas, Inc. · 2000
- 1 generation backK030685 Teeth in an Hour - Ark Implant ConceptNobel Biocare AB · 2004 · Recalled
- This deviceK050393 The Guided Surgery ConceptNobel Biocare AB · 2005
- Descendant · cites it directly · 248 of its ownK053602 Procera Software, Model 33145Nobel Biocare AB · 2006
- Descendant · 2 generations on · 242 of its ownK062493 Lava Software3M Espe AG Dental Products · 2006
- Descendant · 3 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · 2 generations on · 169 of its ownK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- Descendant · 3 generations on · 167 of its ownK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
Showing 5 of 258 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 258 · See all- K053602Procera Software, Model 33145Nobel Biocare AB · 2006 · cites it directly248descendants
- K062493Lava Software3M Espe AG Dental Products · 2006 · 2 generations on242descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 3 generations on240descendants
- K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009 · 2 generations on169descendants
- K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010 · 3 generations on167descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000018 | Branemark Novum | Nobel Biocare Uas, Inc. | 2000 | — |
| −1 | K030685 | Teeth in an Hour - Ark Implant Concept | Nobel Biocare AB | 2004 | 1 |
| 0 (this device) | K050393 | The Guided Surgery Concept | Nobel Biocare AB | 2005 | — |
| +1 | K053602 | Procera Software, Model 33145 | Nobel Biocare AB | 2006 | — |
| +2 | K062493 | Lava Software | 3M Espe AG Dental Products | 2006 | — |
| +3 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +2 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| +3 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 13 | 0 |
| 2017 | 13 | 0 |
| 2018 | 13 | 0 |
| 2019 | 14 | 0 |
| 2020 | 21 | 0 |
| 2021 | 22 | 0 |
| 2022 | 19 | 0 |
| 2023 | 32 | 0 |
| 2024 | 34 | 0 |
| 2025 | 28 | 0 |
| 2026 | 14 | 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 |
|---|---|---|---|
| * | K030685 | Teeth in an Hour - Ark Implant ConceptSummary page 1…Trade or Proprietary or Model Name: The Guided Surgery Concept Legally Marketed Device(s): Teeth in an Hour - ARK Implant Concept (K030685) Device Description: The Guided Surgery Concept is intended for the treatment of totally and partially edentulous jaws as well a… | 2004 |
What descends from it? (258)
See all 2584 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 5 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K053602 (Nobel Biocare AB, 2006) has gone furthest, with 248 descendants of its own.
- 1 other device also cites its predicate K030685.
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 Guided Surgery Concept and Teeth-in-an-Hour are indicated for the treatment of single, partially and totally edentulous jaws for placement of implant fixtures with immediate function to restore patient esthetics and chewing function. The following prerequisites must be fulfilled:
- adequate amount of jaw bone
- the quality of jaw bone must be judged as adequate
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050393: The Guided Surgery Concept.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050393
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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