510(k) · Cleared
ClearedStoma Bone Block Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz AM Mark GmbH · DZL Screw, Fixation, Intraosseous
Cleared on Nov 21, 2008 after a 276-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Nov 21, 2008
- Review
- 276 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 2 citing it directly.
- This deviceK080430 Stoma Bone Block ScrewStorz AM Mark GmbH · 2008
- Descendant · cites it directly · 1 of its ownK201210 The Micro Screw System, Micro Screw System BasicHager& Meisinger GmbH · 2021
- Descendant · 2 generations on · 0 of its ownK254286 Guided Bone Regeneration SystemDentalMaster (Xiamen)Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK103084 Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S · 2011
Most influential descendants
Showing 3 of 3 · See all- K201210The Micro Screw System, Micro Screw System BasicHager& Meisinger GmbH · 2021 · cites it directly1descendant
- K254286Guided Bone Regeneration SystemDentalMaster (Xiamen)Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K103084Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080430 | Stoma Bone Block Screw | Storz AM Mark GmbH | 2008 | — |
| +1 | K201210 | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH | 2021 | — |
| +2 | K254286 | Guided Bone Regeneration System | DentalMaster (Xiamen)Medical Technology Co., Ltd. | 2026 | — |
| +1 | K103084 | Neodent Graft Screw | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K51871 | STOMA Bone Screws Number could not be read Summary page 2…dered separately in different packaging units. 4. Substantial Equivalence Comparison STOMA Bone Block Screws are substantially equivalent to STOMA Bone Screws (K51871). 5. Biocompatibility All requirements of biocompatibility are met through the composition of the used raw material. 6… |
What descends from it? (3)
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?
- Of its descendants, K201210 (Hager& Meisinger GmbH, 2021) has gone furthest, with 1 descendant 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. 2008, 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?
STOMA bone block screws are developed and manufactured to be used as non-active bone surgery Implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field.
STOMA bone block screws are not intended to remain in the body permanently. After they have fulfilled their supportive function such as is the case after healing of a transplant, or healing of a fracture, for example, they need to be removed completely.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080430 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080430: Stoma Bone Block Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080430
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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