510(k) · Cleared
ClearedJ Tac Model JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · DZL Screw, Fixation, Intraosseous
Cleared on Feb 8, 2011 as substantially equivalent to K022790 (BioHorizons Implant Systems, Inc., 2002) after a 215-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Feb 8, 2011
- Review
- 215 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952167 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 2 generations backK973180 Imtec Bone TacImtec Corp. · 1997
- 1 generation backK022790 The Autotac System Titanium TackBioHorizons Implant Systems, Inc. · 2002
- This deviceK101902 J Tac Model JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030Jeil Medical Corporation · 2011
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 | K022790 | The Autotac System Titanium Tack | BioHorizons Implant Systems, Inc. | 2002 | — |
| 0 (this device) | K101902 | J Tac Model JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 | Jeil Medical Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K022790 | The Autotac System Titanium TackSummary page 1…J - Tao Common Name - Membrane fixation pin Classification Name - Screw, fixation, intraosseous 3. Predicate Device: The Autolac; System Titanium Tack, K022790 4. Classifications Names & Citations: DZL, CFR872.4880, Class 2 5. Description: The J - Tao; is a metal device intend… | 2002 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K022790.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 J Tac is intended for use to fixate and stabilize bioresorbable and non-resorbable baffler membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101902: J Tac Model JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101902
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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