510(k) · Cleared
ClearedImtec Bone Tac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imtec Corp. · DZL Screw, Fixation, Intraosseous
Cleared on Nov 18, 1997 as substantially equivalent to K952167 (Interpore Intl., 1995) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.
- Decided
- Nov 18, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952167 (1995). 2 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- This deviceK973180 Imtec Bone TacImtec Corp. · 1997
- Descendant · cites it directly · 6 of its ownK022790 The Autotac System Titanium TackBioHorizons Implant Systems, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK092855 Miltex Membrane Tack KitMiltex, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK130682 Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger…Hager& Meisinger GmbH · 2013
- Descendant · cites it directly · 2 of its ownK100182 Salvin Dental Specialties Fixation ScrewSalvin Dental Specialties, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK201561 Membrane Screws and Membrane TacksNeoss Limited · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K022790The Autotac System Titanium TackBioHorizons Implant Systems, Inc. · 2002 · cites it directly6descendants
- K092855Miltex Membrane Tack KitMiltex, Inc. · 2009 · cites it directly4descendants
- K130682Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit…Hager& Meisinger GmbH · 2013 · cites it directly3descendants
- K100182Salvin Dental Specialties Fixation ScrewSalvin Dental Specialties, Inc. · 2010 · cites it directly2descendants
- K201561Membrane Screws and Membrane TacksNeoss Limited · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952167 | Imz Bone Tack System | Interpore Intl. | 1995 | — |
| 0 (this device) | K973180 | Imtec Bone Tac | Imtec Corp. | 1997 | — |
| +1 | K022790 | The Autotac System Titanium Tack | BioHorizons Implant Systems, Inc. | 2002 | — |
| +1 | K092855 | Miltex Membrane Tack Kit | Miltex, Inc. | 2009 | — |
| +1 | K130682 | Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger… | Hager& Meisinger GmbH | 2013 | — |
| +1 | K100182 | Salvin Dental Specialties Fixation Screw | Salvin Dental Specialties, Inc. | 2010 | — |
| +2 | K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K952167 | Imz Bone Tack SystemSummary page 1…DZL Common/Usual Name: Bone Tack, Bone Screw or Bone Fixation Device. Proprietary Name: IMTEC Bone Tac PREDICATE DEVICE: Interpore International, IMZ Bone Tack System, K952167 Interpore International, IMZ Membrane Tack System, K960945 DEVICE DESCRIPTION: The IMTEC Bone Tac is fabricated of titanium all… | 1995 |
| * | K960945 | Imz Membrane Tack SystemSummary page 1…on Device. Proprietary Name: IMTEC Bone Tac PREDICATE DEVICE: Interpore International, IMZ Bone Tack System, K952167 Interpore International, IMZ Membrane Tack System, K960945 DEVICE DESCRIPTION: The IMTEC Bone Tac is fabricated of titanium alloy and has a thin low profile head and a barb at the tip fo… | 1996 |
What descends from it? (10)
4 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?
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 | — |
What is it indicated for?
The IMTEC Bone Tac System is designed to stabilize a Barrier Membrane onto a region
of cortical plate. This may be used in craniofacial, maxillofacial or mandibular bone.
Considerations such as quality of bone, bone type, functional loads exerted, general
patient health and others should be carefully evaluated prior to use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973180: Imtec Bone Tac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973180
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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