510(k) · Cleared
ClearedAce Bone Screw Tacking Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Surgical Supply Co., Inc. · DZL Screw, Fixation, Intraosseous
Cleared on Aug 25, 1995 after a 144-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 51 later devices descend from it.
- Decided
- Aug 25, 1995
- Review
- 144 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 0
51 later devices descend from it, 1 citing it directly.
- This deviceK951510 Ace Bone Screw Tacking KitAce Surgical Supply Co., Inc. · 1995
- Descendant · cites it directly · 50 of its ownK970499 Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997
- Descendant · 2 generations on · 32 of its ownK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
- Descendant · 2 generations on · 31 of its ownK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
- Descendant · 3 generations on · 24 of its ownK061169 Endosseous Dental ImplantNorthern Implants, LLC · 2006
- Descendant · 3 generations on · 21 of its ownK070841 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K970499Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997 · cites it directly50descendants
- K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004 · 2 generations on32descendants
- K052490Endosseous Dental Implant SystemNorthern Implants, LLC · 2005 · 2 generations on31descendants
- K061169Endosseous Dental ImplantNorthern Implants, LLC · 2006 · 3 generations on24descendants
- K070841Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951510 | Ace Bone Screw Tacking Kit | Ace Surgical Supply Co., Inc. | 1995 | — |
| +1 | K970499 | Branemark System Zygomaticus Fixture System | Nobel Biocare Uas, Inc. | 1997 | — |
| +2 | K033171 | Nsi Hexed and Non-Hexed Implant System and Immediate Loading | Northern Implants, LLC | 2004 | — |
| +2 | K052490 | Endosseous Dental Implant System | Northern Implants, LLC | 2005 | — |
| +3 | K061169 | Endosseous Dental Implant | Northern Implants, LLC | 2006 | — |
| +3 | K070841 | Endosseous Dental Implant System | Southern Implants, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (51)
See all 511 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970499 | Branemark System Zygomaticus Fixture System | 1997 | 50 |
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?
- Of its descendants, K970499 (Nobel Biocare Uas, Inc., 1997) has gone furthest, with 50 descendants of its own.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K951510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951510: Ace Bone Screw Tacking Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951510
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026