510(k) · Cleared
Recalled · Class II · 2019Teeth in an Hour - Ark Implant 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 Feb 6, 2004 as substantially equivalent to K000018 (Nobel Biocare Uas, Inc., 2000) and 1 other predicate after a 338-day review. Its family tree reaches back 1 generation to 2000. 259 later devices descend from it. It has been recalled once.
- Decided
- Feb 6, 2004
- Review
- 338 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000018 (2000). 2 ancestors in all. 259 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000018 Branemark NovumNobel Biocare Uas, Inc. · 2000
- This deviceK030685 Teeth in an Hour - Ark Implant ConceptNobel Biocare AB · 2004
- Descendant · cites it directly · 258 of its ownK050393 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
Showing 5 of 259 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 259 · See all- K050393The Guided Surgery ConceptNobel Biocare AB · 2005 · cites it directly258descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000018 | Branemark Novum | Nobel Biocare Uas, Inc. | 2000 | — |
| 0 (this device) | K030685 | Teeth in an Hour - Ark Implant Concept | Nobel Biocare AB | 2004 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K000018 | Branemark NovumSummary page 1…872.3640) Trade or Proprietary or Model Name: Teeth in an Hour - ARK Implant Concept Legally Marketed Device(s): Branemark Novum (K000018) Branemnark System Implants - Immediate Function Indication (K022562) Device Descriptio… | 2000 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 1…Legally Marketed Device(s): Branemark Novum (K000018) Branemnark System Implants - Immediate Function Indication (K022562) Device Description: The Teeth in and Hour - ARK Implant System is a concept bridging the use of existing modeling techniques to… | 2002 |
What descends from it? (259)
See all 2592 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2019 | Class II | Z-1302-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Teeth in an Hour - ARK Implant System is indicated for the treatment of totally edentulous jaws for placement of implant fixtures with immediate load function to restore the patient's chewing function. The following prerequisites must be fuffilled:
* adequate amount of jaw bone
* the quality of jaw bone must be judged as adequate
* capability to open the mouth at least 50mm (this is especially important for lower jaws with teeth in the opposite jaw)
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/K030685 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030685: Teeth in an Hour - Ark Implant Concept.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030685
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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