510(k) · Cleared
ClearedSave GBR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentis Co., Ltd. · DZL Screw, Fixation, Intraosseous
Cleared on Mar 23, 2023 as substantially equivalent to K170697 (Surgident, 2018) after a 230-day review. Its family tree reaches back 10 generations to 1976.
- Decided
- Mar 23, 2023
- Review
- 230 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K761228 (1976). 81 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 6 generations between
- 3 generations backK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
- 2 generations backK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- 1 generation backK170697 GBR systemSurgident · 2018
- This deviceK222367 Save GBRDentis Co., Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 9 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 8 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 7 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 6 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 5 generations backK022890 Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone…Bioplate, Inc. · 2002
- 4 generations backK030806 Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2003
- 3 generations backK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
- 2 generations backK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- 1 generation backK170697 GBR systemSurgident · 2018
- This deviceK222367 Save GBRDentis Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −9 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −8 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −7 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −6 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −5 | K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating… | Bioplate, Inc. | 2002 | — |
| −4 | K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery | Bioplate, Inc. | 2003 | — |
| −3 | K091812 | Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible… | Frontier Devices, Inc. | 2010 | — |
| −2 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| −1 | K170697 | GBR system | Surgident | 2018 | — |
| 0 (this device) | K222367 | Save GBR | Dentis Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 10 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K170697 | GBR systemSummary page 4…• Product Code: DZL • Panel: Dental • Regulation Number: 872.4880 • Device Class: Class II • Date prepared: 03/23/2023 Primary Predicate: K170697, GBR System by Surgident Reference Device: K182881, Bone Screw, Bone Tack by Osstem Implant Co., Ltd. Indications for Use: The… | 2018 |
| † | K182881 | Bone Screw, Bone Tack | 2019 |
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 47 years and passes through 9 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 81 ancestors have a recall of any class.
- 1 other device also cites its predicate K170697.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222367: Save GBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222367
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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