510(k) · Cleared
ClearedHDC Sterile 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 Oct 18, 2007 as substantially equivalent to K052471 (Hdc S.R.L., 2005) and 2 other predicates after a 105-day review. Its family tree reaches back 7 generations to 1990. 2 later devices descend from it.
- Decided
- Oct 18, 2007
- Review
- 105 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K894844 (1990). 22 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations backK973353 Bonding BaseStraumann USA · 1997
- 5 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 4 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 3 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 2 generations backK042965 Tomas PinDentaurum, Inc. · 2005
- 1 generation backK052471 HDC Spider ScrewHdc S.R.L. · 2005
- This deviceK071851 HDC Sterile Spider ScrewHdc S.R.L. · 2007
- Descendant · cites it directly · 0 of its ownK122069 Storm Mini ScrewLancer Orthodontics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK091390 HDC Sterile Self Ligating Spider Screw, Model Sli,SL2Hdc S.R.L. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −6 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −5 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −4 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −3 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −2 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| −1 | K052471 | HDC Spider Screw | Hdc S.R.L. | 2005 | — |
| 0 (this device) | K071851 | HDC Sterile Spider Screw | Hdc S.R.L. | 2007 | — |
| +1 | K122069 | Storm Mini Screw | Lancer Orthodontics, Inc. | 2013 | — |
| +1 | K091390 | HDC Sterile Self Ligating Spider Screw, Model Sli,SL2 | Hdc S.R.L. | 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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K052471 | HDC Spider ScrewSummary page 1…21 CFR 872.3640, Product Code DZE 510 K Device Trade Name Manufacturer Number K052471 Spider Screw HDC K062733 Tomas-pin Dentaurum… | 2005 |
| * | K062733 | Tomas Pin SD 6, 8, and 10 MMSummary page 1…510 K Device Trade Name Manufacturer Number K052471 Spider Screw HDC K062733 Tomas-pin Dentaurum K033767 Dual Top Anchor System Jeil… | 2006 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…Number K052471 Spider Screw HDC K062733 Tomas-pin Dentaurum K033767 Dual Top Anchor System Jeil Medical Sterile Spider Screw - 510(k) File… | 2004 |
What descends from it? (2)
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 17 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- None of the 22 ancestors has a recall.
- Of its descendants, K122069 (Lancer Orthodontics, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052471.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Sterile 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. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071851: HDC Sterile Spider Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071851
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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