510(k) · Cleared
ClearedAlpha Bio Bone Fixation Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha-Bio Tec, Ltd. · DZL Screw, Fixation, Intraosseous
Cleared on Mar 30, 2007 as substantially equivalent to K050515 (Straumann USA, Inc., 2005) and 1 other predicate after a 100-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 30, 2007
- Review
- 100 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K952167 (1995). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 2 generations backK960914 3I Osseous Fixation System (S)Implant Innovations, Inc. · 1996
- 1 generation backK011698 Straumann GBR SystemInstitut Straumann AG · 2001
- This deviceK063769 Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007
- Descendant · cites it directly · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
- Descendant · 3 generations on · 0 of its ownK222367 Save GBRDentis Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · cites it directly3descendants
- K170697GBR systemSurgident · 2018 · 2 generations on2descendants
- K222367Save GBRDentis Co., Ltd. · 2023 · 3 generations on0descendants
- K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952167 | Imz Bone Tack System | Interpore Intl. | 1995 | — |
| −2 | K960914 | 3I Osseous Fixation System (S) | Implant Innovations, Inc. | 1996 | — |
| −1 | K011698 | Straumann GBR System | Institut Straumann AG | 2001 | — |
| 0 (this device) | K063769 | Alpha Bio Bone Fixation Screw System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +1 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +2 | K170697 | GBR system | Surgident | 2018 | — |
| +3 | K222367 | Save GBR | Dentis Co., Ltd. | 2023 | — |
| +3 | K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K050515 | Bone Block Fixation SetSummary page 1…ass: II Panel: Dental F. Predicate Devices: The Alpha-Bin Bone Fixation Screw System is substantially equivalent to Straumann K050515; KOI 1698; in terms of intended use, indications for use, technological characteristics,… | 2005 |
| * | K011698 | Straumann GBR System | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141764 | Tristar Bone Graft Fixation System | 2014 | 3 |
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 12 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K141764 (Impladent, Ltd., 2014) has gone furthest, with 3 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. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Alpha-Bio Bone Fixation Screw System® is used to stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063769: Alpha Bio Bone Fixation 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/K063769
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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