510(k) · Cleared
ClearedScrewline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altatec Biotechnologies N.A., Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 14, 2002 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 83 later devices descend from it.
- Decided
- Aug 14, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
83 later devices descend from it, 5 citing it directly.
- This deviceK022425 ScrewlineAltatec Biotechnologies N.A., Inc. · 2002
- Descendant · cites it directly · 66 of its ownK061477 Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsNobel Biocare AB · 2006
- Descendant · 2 generations on · 34 of its ownK093643 Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB · 2010
- Descendant · cites it directly · 33 of its ownK061478 Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB · 2006
- Descendant · 2 generations on · 32 of its ownK103252 Camlog Vario SR AbutmentsAltatec GmbH · 2011
- Descendant · cites it directly · 26 of its ownK061529 Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB · 2006
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K061477Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsNobel Biocare AB · 2006 · cites it directly66descendants
- K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB · 2010 · 2 generations on34descendants
- K061478Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB · 2006 · cites it directly33descendants
- K103252Camlog Vario SR AbutmentsAltatec GmbH · 2011 · 2 generations on32descendants
- K061529Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB · 2006 · cites it directly26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022425 | Screwline | Altatec Biotechnologies N.A., Inc. | 2002 | — |
| +1 | K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems | Nobel Biocare AB | 2006 | — |
| +2 | K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant Systems | Nobel Biocare AB | 2010 | — |
| +1 | K061478 | Procera Titanium Abutment for Astratech and Camlog Implant Systems | Nobel Biocare AB | 2006 | — |
| +2 | K103252 | Camlog Vario SR Abutments | Altatec GmbH | 2011 | — |
| +1 | K061529 | Procera Zirconia Abutment for Camlog Implant System | Nobel Biocare AB | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (83)
See all 835 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems | 2006 | 66 |
| K061478 | Procera Titanium Abutment for Astratech and Camlog Implant Systems | 2006 | 33 |
| K061529 | Procera Zirconia Abutment for Camlog Implant System | 2006 | 26 |
| K110640 | Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later Abutment | 2011 | 9 |
| K073217 | Inclusive Implant Abutments | 2008 | 3 |
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?
- Of its descendants, K061477 (Nobel Biocare AB, 2006) has gone furthest, with 66 descendants of its own.
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?
ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments, long span to bridgework, as distal abutments on free-standing edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022425: Screwline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022425
Report an extraction error
Are you the manufacturer?
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