510(k) · Cleared
ClearedSyntec Wetali Orthodontic Mini Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntec Scientific Corporation - Taipei Office · OAT Implant, Endosseous, Orthodontic
Cleared on Mar 18, 2015 as substantially equivalent to K090476 (Syntec Scientific Corp., 2009) after a 238-day review. Its family tree reaches back 9 generations to 1990. 1 later device descends from it.
- Decided
- Mar 18, 2015
- Review
- 238 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894844 (1990). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations between
- 3 generations backK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- 2 generations backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- 1 generation backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- This deviceK142001 Syntec Wetali Orthodontic Mini ScrewsSyntec Scientific Corporation - Taipei Office · 2015
- Descendant · cites it directly · 0 of its ownK202163 Mico One Orthodontic ScrewZe Fang Technology Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations backK973353 Bonding BaseStraumann USA · 1997
- 7 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 6 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 5 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 4 generations backK042965 Tomas PinDentaurum, Inc. · 2005
- 3 generations backK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- 2 generations backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- 1 generation backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- This deviceK142001 Syntec Wetali Orthodontic Mini ScrewsSyntec Scientific Corporation - Taipei Office · 2015
Most influential descendants
Showing 1 of 1 · See all- K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −8 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −7 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −6 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −5 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −4 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| −3 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| −2 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| −1 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
| 0 (this device) | K142001 | Syntec Wetali Orthodontic Mini Screws | Syntec Scientific Corporation - Taipei Office | 2015 | — |
| +1 | K202163 | Mico One Orthodontic Screw | Ze Fang Technology Co., Ltd. | 2022 | — |
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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 OAT? 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 OAT device
- #1 K260268 OrthoEasy Pal; OrthoEasy Pal Long Neckscore 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K090476 | Syntec Orthodontic Mini ScrewSummary page 4…gulation number: 872.3640 Class: Class II Predicate devices: Syntec Orthodontic Mini Screws (K090476) 1. Description of the Device The screws are manufactured from commercially SUS316L (stainless steel) and Ti6AL-4V (Titan… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202163 | Mico One Orthodontic Screw | 2022 | 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 25 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K202163 (Ze Fang Technology Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K090476.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OAT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAT
224in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAT
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAT
5in 2025
MAUDE reports naming product code OAT, 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 | 6 | 104 | 2 | 2 |
| 2008 | 3 | 94 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 152 | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 28 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 289 | 0 | 38 |
| 2021 | 4 | 224 | 0 | 68 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 1 | — | 0 | 78 |
| 2024 | 2 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
THE SCREWS ARE INDICATED FOR USE AS A FIXED ANCHORAGE FOR ATTACHMENT OF ORTHODONTIC APPLIANCES TO FACILITATE THE ORTHODONTIC MOVEMENT OF TEETH. THEY ARE USED TEMPORARILY AND ARE REMOVED AFTER ORTHODONTIC TREATMENT HAS BEEN COMPLETED. THEY ARE INTENDED FOR SINGLE USE ONLY.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142001 · printed Nov 3, 2026
Cite this page
510(k) Report. “K142001: Syntec Wetali Orthodontic Mini Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142001
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