510(k) · Cleared
ClearedHDC Spider Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hdc S.R.L. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 23, 2005 as substantially equivalent to K042965 (Dentaurum, Inc., 2005) and 3 other predicates after a 106-day review. Its family tree reaches back 6 generations to 1990. 4 later devices descend from it.
- Decided
- Dec 23, 2005
- Review
- 106 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K894844 (1990). 20 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations backK973353 Bonding BaseStraumann USA · 1997
- 4 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 3 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 2 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 1 generation backK042965 Tomas PinDentaurum, Inc. · 2005
- This deviceK052471 HDC Spider ScrewHdc S.R.L. · 2005
- Descendant · cites it directly · 2 of its ownK071851 HDC Sterile Spider ScrewHdc S.R.L. · 2007
- Descendant · 2 generations on · 0 of its ownK122069 Storm Mini ScrewLancer Orthodontics, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK091390 HDC Sterile Self Ligating Spider Screw, Model Sli,SL2Hdc S.R.L. · 2009
- Descendant · cites it directly · 0 of its ownK083869 BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S)…Btlock Srl · 2009
Most influential descendants
Showing 4 of 4 · See all- K071851HDC Sterile Spider ScrewHdc S.R.L. · 2007 · cites it directly2descendants
- K122069Storm Mini ScrewLancer Orthodontics, Inc. · 2013 · 2 generations on0descendants
- K091390HDC Sterile Self Ligating Spider Screw, Model Sli,SL2Hdc S.R.L. · 2009 · 2 generations on0descendants
- K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −5 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −4 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −3 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −2 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −1 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| 0 (this device) | K052471 | HDC Spider Screw | Hdc S.R.L. | 2005 | — |
| +1 | K071851 | HDC Sterile Spider Screw | Hdc S.R.L. | 2007 | — |
| +2 | K122069 | Storm Mini Screw | Lancer Orthodontics, Inc. | 2013 | — |
| +2 | K091390 | HDC Sterile Self Ligating Spider Screw, Model Sli,SL2 | Hdc S.R.L. | 2009 | — |
| +1 | K083869 | BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3… | Btlock Srl | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 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? (4)
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 |
|---|---|---|---|
| * | K042965 | Tomas PinSummary page 1…Class 11, 21 CFR 872.3640. Product Code DZF. Predicate Devices: 510 K Number Device Trade Name Manufacturer K042965 Tomas-pin Dentaurum K033767 Dual Top Anchor System… | 2005 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…510 K Number Device Trade Name Manufacturer K042965 Tomas-pin Dentaurum K033767 Dual Top Anchor System Jeil Medical K041527 AARHUS Anchorage System… | 2004 |
| * | K041527 | Aarhus Anchorage SystemSummary page 1…K042965 Tomas-pin Dentaurum K033767 Dual Top Anchor System Jeil Medical K041527 AARHUS Anchorage System K021584 Replace Scalloped Margin Implant System Nobel Biocare ===… | 2004 |
| * | K021584 | Replace Scalloped Margin Implant SystemSummary page 1…Dentaurum K033767 Dual Top Anchor System Jeil Medical K041527 AARHUS Anchorage System K021584 Replace Scalloped Margin Implant System Nobel Biocare HDC Spider Screw 510(k)… | 2002 |
What descends from it? (4)
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 15 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K071851 (Hdc S.R.L., 2007) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K042965.
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?
The HDC Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052471 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052471: HDC Spider Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052471
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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