510(k) · Cleared
ClearedSalvin Dental Specialties Fixation Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salvin Dental Specialties, Inc. · DZL Screw, Fixation, Intraosseous
Cleared on May 10, 2010 as substantially equivalent to K973180 (Imtec Corp., 1997) after a 109-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- May 10, 2010
- Review
- 109 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952167 (1995). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 1 generation backK973180 Imtec Bone TacImtec Corp. · 1997
- This deviceK100182 Salvin Dental Specialties Fixation ScrewSalvin Dental Specialties, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK151540 MC BIO Supertack Tack 3mm, 4mm and 5mmEli-Ka Technologies · 2016
- Descendant · 2 generations on · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952167 | Imz Bone Tack System | Interpore Intl. | 1995 | — |
| −1 | K973180 | Imtec Bone Tac | Imtec Corp. | 1997 | — |
| 0 (this device) | K100182 | Salvin Dental Specialties Fixation Screw | Salvin Dental Specialties, Inc. | 2010 | — |
| +1 | K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mm | Eli-Ka Technologies | 2016 | — |
| +2 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K973180 | Imtec Bone TacSummary page 1…ation System Classification Name Screw, Fixation, Intraosseous (21 CFR 872.4880, Product code DZL) C Predicate Device(s) K973 180 - IMTEC Bone Tac D Device Description The Salvin Bone Tack System consists of 3mm and 5mm… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mm | 2016 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K151540 (Eli-Ka Technologies, 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K973180.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Salvin Bone Tack System is designed to stabilize a barrier membrane onto a region of contical 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 evdluated prior to use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100182: Salvin Dental Specialties Fixation Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100182
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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