510(k) · Cleared
ClearedDental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX Professional
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hager& Meisinger GmbH · DZL Screw, Fixation, Intraosseous
Cleared on Feb 14, 2014 as substantially equivalent to K051871 (Storz AM Mark GmbH, 2005) and 1 other predicate after a 213-day review. Its family tree reaches back 4 generations to 1982.
- Decided
- Feb 14, 2014
- Review
- 213 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K820944 (1982). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 3 generations backK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
- 2 generations backK980760 KLS-Martin MMF ScrewKLS-Martin L.P. · 1999
- 1 generation backK051871 Stoma Bone ScrewStorz AM Mark GmbH · 2005
- This deviceK132212 Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX…Hager& Meisinger GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −3 | K963030 | Leibinger Imf Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K980760 | KLS-Martin MMF Screw | KLS-Martin L.P. | 1999 | — |
| −1 | K051871 | Stoma Bone Screw | Storz AM Mark GmbH | 2005 | — |
| 0 (this device) | K132212 | Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw… | Hager& Meisinger GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K051871 | Stoma Bone ScrewSummary page 1…ulation No: 872.4880 Class: 11 Panel: Dental 4. Predicate Devices: K051871 - Storz am Markt Bone Screws K041 887 - Synthes Craniofacial Screws 5. Device Descr… | 2005 |
| * | K041887 | Synthes (Usa) 1.0/1.22 MM Craniofacial ScrewsSummary page 1…11 Panel: Dental 4. Predicate Devices: K051871 - Storz am Markt Bone Screws K041 887 - Synthes Craniofacial Screws 5. Device Description: The Meisinger Dental Bone Screws… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 5 companies; a new generation was cleared every 8.3 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Meisinger Dental Bone Screws are intended for fixation of bone segments e.g. for horizontal or vertical augmentative grafts. Depending an indication the user choose the matching screw, prepares the pit hole and inserts the screw. The screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132212: Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX Professional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132212
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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