510(k) · Cleared
ClearedSuper Orthodontic Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 20, 2006 as substantially equivalent to K031936 (Osteomed LP, 2004) and 1 other predicate after an 84-day review. Its family tree reaches back 5 generations to 1990. 6 later devices descend from it.
- Decided
- Oct 20, 2006
- Review
- 84 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. 6 later devices descend from it, 2 citing it directly.
- 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 deviceK062156 Super Orthodontic ScrewOsstem Implant Co., Ltd. · 2006
- Descendant · cites it directly · 4 of its ownK103105 Orthodontic ScrewOsstem Implant Co., Ltd. · 2011
- Descendant · 2 generations on · 2 of its ownK161197 Orthodontic ScrewOsstem Implant Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK231502 Mini ScrewsProimtech Saglik Urunleri Anonim Sirketi · 2024
- Descendant · 2 generations on · 0 of its ownK211992 Ortho MI SystemOsteonic Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK190871 Bio-TackS Orthodontic Mini ImplantBiocetec Co., Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K103105Orthodontic ScrewOsstem Implant Co., Ltd. · 2011 · cites it directly4descendants
- K161197Orthodontic ScrewOsstem Implant Co., Ltd. · 2016 · 2 generations on2descendants
- K231502Mini ScrewsProimtech Saglik Urunleri Anonim Sirketi · 2024 · 3 generations on0descendants
- K211992Ortho MI SystemOsteonic Co., Ltd. · 2021 · 2 generations on0descendants
- K190871Bio-TackS Orthodontic Mini ImplantBiocetec Co., Ltd. · 2020 · 3 generations on0descendants
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) | K062156 | Super Orthodontic Screw | Osstem Implant Co., Ltd. | 2006 | — |
| +1 | K103105 | Orthodontic Screw | Osstem Implant Co., Ltd. | 2011 | — |
| +2 | K161197 | Orthodontic Screw | Osstem Implant Co., Ltd. | 2016 | — |
| +3 | K231502 | Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi | 2024 | — |
| +2 | K211992 | Ortho MI System | Osteonic Co., Ltd. | 2021 | — |
| +3 | K190871 | Bio-TackS Orthodontic Mini Implant | Biocetec Co., Ltd. | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K031936 | Osteomed Orthodontic Screw SystemSummary page 1…Common Name - Dental Implant Classification Name - Endosseous dental implant 3. Predicate Device: Osteomed Orthodontic Screw System, Osteomed L.P., K031936 Dual Top Anchor System Screws, Jeil Medical Corporation, K033767 4. Classifications Names & Citations: 21CFR 872… | 2004 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…s dental implant 3. Predicate Device: Osteomed Orthodontic Screw System, Osteomed L.P., K031936 Dual Top Anchor System Screws, Jeil Medical Corporation, K033767 4. Classifications Names & Citations: 21CFR 872.3640, DZE, Endosseous dental implant, Classll 5. Description: T… | 2004 |
What descends from it? (6)
2 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 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K103105 (Osstem Implant Co., Ltd., 2011) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K031936.
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?
Super Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily 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/K062156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062156: Super Orthodontic Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062156
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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