510(k) · Cleared
ClearedOsteomed Orthodontic Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · DZE Implant, Endosseous, Root-Form
Cleared on Jan 7, 2004 as substantially equivalent to K982509 (Straumann USA, 1998) and 1 other predicate after a 198-day review. Its family tree reaches back 3 generations to 1990. 63 later devices descend from it.
- Decided
- Jan 7, 2004
- Review
- 198 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894844 (1990). 14 ancestors in all. 63 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 2 generations backK973353 Bonding BaseStraumann USA · 1997
- 1 generation backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- This deviceK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- Descendant · cites it directly · 54 of its ownK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- Descendant · cites it directly · 26 of its ownK042965 Tomas PinDentaurum, Inc. · 2005
- Descendant · 2 generations on · 19 of its ownK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- Descendant · 3 generations on · 14 of its ownK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- Descendant · 4 generations on · 13 of its ownK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K033767Dual Top Anchor System ScrewsJeil Medical Corporation · 2004 · cites it directly54descendants
- K042965Tomas PinDentaurum, Inc. · 2005 · cites it directly26descendants
- K060126Absoanchor MicroimplantDentos, Inc. · 2006 · 2 generations on19descendants
- K071490Leone Orthodontic Mini ImplantLeone S.P.A. · 2008 · 3 generations on14descendants
- K090476Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −2 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −1 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| 0 (this device) | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| +1 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| +1 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| +2 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| +3 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| +4 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K982509 | Ortho Implant and AccessoriesSummary page 1…Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Straumann Ortho Implant (K982509) and the Nobel Biocare Inplant Orthodontic Anchor System (K00064 3). Due to the similarity of… | 1998 |
| * | K000643 | Inplant Orthodontic Anchor SystemSummary page 1…ial, design and operational principle to the Straumann Ortho Implant (K982509) and the Nobel Biocare Inplant Orthodontic Anchor System (K00064 3). Due to the similarity of materials and design to the predicate device, OsteoMed believes tha… | 2000 |
What descends from it? (63)
See all 638 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033767 | Dual Top Anchor System Screws | 2004 | 54 |
| K042965 | Tomas Pin | 2005 | 26 |
| K062733 | Tomas Pin SD 6, 8, and 10 MM | 2006 | 6 |
| K062156 | Super Orthodontic Screw | 2006 | 6 |
| K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model… | 2006 | 6 |
| K050568 | Orlus Mini Screw | 2005 | 5 |
| K063770 | Alpha-Bio Orthodontic Fixation Screw System | 2007 | 1 |
| K072917 | JJG Evolution Orthodontic Implant System | 2008 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K033767 (Jeil Medical Corporation, 2004) has gone furthest, with 54 descendants of its own.
- 5 other devices also cite its predicate K982509.
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?
Indicated to provide 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/K031936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031936: Osteomed Orthodontic Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031936
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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