510(k) · Cleared
ClearedGBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proimtech Saglik Urunleri Anonim Sirketi · DZL Screw, Fixation, Intraosseous
Cleared on Jan 3, 2025 as substantially equivalent to K011698 (Institut Straumann AG, 2001) after a 451-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jan 3, 2025
- Review
- 451 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. No later device cites it as a predicate yet.
- Root · 3 generations backK952167 Imz Bone Tack SystemInterpore Intl. · 1995
- 2 generations backK960914 3I Osseous Fixation System (S)Implant Innovations, Inc. · 1996
- 1 generation backK011698 Straumann GBR SystemInstitut Straumann AG · 2001
- This deviceK233419 GBR SystemProimtech Saglik Urunleri Anonim Sirketi · 2025
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 | K960914 | 3I Osseous Fixation System (S) | Implant Innovations, Inc. | 1996 | — |
| −1 | K011698 | Straumann GBR System | Institut Straumann AG | 2001 | — |
| 0 (this device) | K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K011698 | Straumann GBR SystemSummary page 7…e and torque. The GBR System is labeled as MR conditional. Legally Marketed Device to Which Claim Substantial Equivalence: For primary device GBR System: K011698; Straumann GBR System Straumann USA For reference device GBR System: K182881; Bone Tack, OSSTEM Implant Co., Ltd. For reference… | 2001 |
| † | K182881 | Bone Screw, Bone Tack | 2019 |
| † | K161857 | Salvin Tenting Screw System | 2017 |
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 30 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K011698.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Guided Bone Regeneration (GBR) System is used to stabilize and fix bone grafts, bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
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/K233419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233419: GBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233419
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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