510(k) · Cleared
ClearedMC BIO Supertack Tack 3mm, 4mm and 5mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eli-Ka Technologies · DZL Screw, Fixation, Intraosseous
Cleared on May 26, 2016 as substantially equivalent to K100182 (Salvin Dental Specialties, Inc., 2010) after a 353-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- May 26, 2016
- Review
- 353 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952167 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 2 generations backK973180 Imtec Bone TacImtec Corp. · 1997
- 1 generation backK100182 Salvin Dental Specialties Fixation ScrewSalvin Dental Specialties, Inc. · 2010
- This deviceK151540 MC BIO Supertack Tack 3mm, 4mm and 5mmEli-Ka Technologies · 2016
- Descendant · cites it directly · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020 · cites it directly0descendants
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 | K973180 | Imtec Bone Tac | Imtec Corp. | 1997 | — |
| −1 | K100182 | Salvin Dental Specialties Fixation Screw | Salvin Dental Specialties, Inc. | 2010 | — |
| 0 (this device) | K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mm | Eli-Ka Technologies | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100182 | Salvin Dental Specialties Fixation ScrewSummary page 4…Classification Name: Intra-osseous fixation screw or wire Product Code: DZL Classification Regulation: 21 CFR 872.4880 Class: II PREDICATE DEVICE ( PRIMARY ): K100182 - SALVIN Bone Tack 3mm and 5mm REFERENCE PREDICATE DEVICE : Company Trade… | 2010 |
| † | K022790 | The Autotac System Titanium Tack | 2002 |
| † | K130682 | Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit… | 2013 |
| † | K973180 | Imtec Bone Tac | 1997 |
| † | K101835 | Medpor Fixation System-Cranial, Models 80080, 80079 | 2010 |
| † | K122069 | Storm Mini Screw | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182759 | BoniPlus Dental G-Mesh System | 2020 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K182759 (Montjade Engineering Co., Ltd., 2020) has gone furthest, with 0 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. 2016, 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 MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area.
The MC Bio SUPERTACK system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.
General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151540: MC BIO Supertack Tack 3mm, 4mm and 5mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151540
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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