510(k) · Cleared
ClearedMeisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit, Basic-Kit
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 Aug 13, 2013 as substantially equivalent to K092855 (Miltex, Inc., 2009) and 1 other predicate after a 153-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Aug 13, 2013
- Review
- 153 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K952167 (1995). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 3 generations backK973180 Imtec Bone TacImtec Corp. · 1997
- 2 generations backK022790 The Autotac System Titanium TackBioHorizons Implant Systems, Inc. · 2002
- 1 generation backK092855 Miltex Membrane Tack KitMiltex, Inc. · 2009
- This deviceK130682 Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger…Hager& Meisinger GmbH · 2013
- Descendant · cites it directly · 1 of its ownK201561 Membrane Screws and Membrane TacksNeoss Limited · 2020
- Descendant · 2 generations on · 0 of its ownK243190 USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025
- Descendant · cites it directly · 0 of its ownK240321 MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH · 2024
Most influential descendants
Showing 3 of 3 · See all- K201561Membrane Screws and Membrane TacksNeoss Limited · 2020 · cites it directly1descendant
- K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG · 2025 · 2 generations on0descendants
- K240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952167 | Imz Bone Tack System | Interpore Intl. | 1995 | — |
| −3 | K973180 | Imtec Bone Tac | Imtec Corp. | 1997 | — |
| −2 | K022790 | The Autotac System Titanium Tack | BioHorizons Implant Systems, Inc. | 2002 | — |
| −1 | K092855 | Miltex Membrane Tack Kit | Miltex, Inc. | 2009 | — |
| 0 (this device) | K130682 | Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger… | Hager& Meisinger GmbH | 2013 | — |
| +1 | K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | 2020 | — |
| +2 | K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025 | — |
| +1 | K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K092855 | Miltex Membrane Tack KitSummary page 1…L Regulation No: 872.4880 Class: 11 Panel: Dental Predicate Devices: K092855 Miltexe Membrane Tack Kit K973180 IMTEC Bone Tac Device Description: The… | 2009 |
| * | K973180 | Imtec Bone TacSummary page 1…11 Panel: Dental Predicate Devices: K092855 Miltexe Membrane Tack Kit K973180 IMTEC Bone Tac Device Description: The Meisinger Tacs and Pins consist of titanium… | 1997 |
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?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K201561 (Neoss Limited, 2020) 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. 2013, 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?
Tacs and Pins are used for the fixation of membranes (resarbable membranes non-resorbable membranes) to the bone structure.
Taos and Pins are intended far single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130682: Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit, Basic-Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130682
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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