510(k) · Cleared
ClearedAnchor Plus/Neo Anchor Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kj Meditech · DZE Implant, Endosseous, Root-Form
Cleared on May 31, 2006 as substantially equivalent to K000643 (Nobel Biocare Uas, Inc., 2000) and 1 other predicate after a 153-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- May 31, 2006
- Review
- 153 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894844 (1990). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK973353 Bonding BaseStraumann USA · 1997
- 3 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 2 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 1 generation backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- This deviceK053629 Anchor Plus/Neo Anchor PlusKj Meditech · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −3 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −2 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −1 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| 0 (this device) | K053629 | Anchor Plus/Neo Anchor Plus | Kj Meditech | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 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 |
|---|---|---|---|
| * | K000643 | Inplant Orthodontic Anchor SystemSummary page 1…assification Name - Endosseous Dental Implant 3. Predicate Device: 1) Nobel Biocare USA, Inc. Nobel Biocare's InPlant TM Orthodontic Anchor System K000643(Decision Date - 10/07/2000) 2) Jeil Medical Corporation Dual Top Anchor Systems Screws K033767(Decision Date -… | 2000 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…Biocare's InPlant TM Orthodontic Anchor System K000643(Decision Date - 10/07/2000) 2) Jeil Medical Corporation Dual Top Anchor Systems Screws K033767(Decision Date - 02/24/2004) 4. Classifications Names & Citations: -31- KJ MEDITECH… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 16 ancestors has a recall.
- 5 other devices also cite its predicate K000643.
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?
This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used for anchorage and is removed after orthodontic treatment has been completed.
Screws are intended for single use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053629: Anchor Plus/Neo Anchor Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053629
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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