510(k) · Cleared
ClearedNeodent Graft Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jjgc Industria E Comercio DE Materiais Dentarios S · DZL Screw, Fixation, Intraosseous
Cleared on Feb 14, 2011 as substantially equivalent to K073342 (Salvin Dental Specialties, Inc., 2008) and 1 other predicate after a 118-day review. Its family tree reaches back 6 generations to 1976.
- Decided
- Feb 14, 2011
- Review
- 118 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K761228 (1976). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 5 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 4 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 3 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 2 generations backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- 1 generation backK073342 Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 2008
- This deviceK103084 Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −5 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −2 | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| −1 | K073342 | Salvin Dental Specialties, Inc., Fixation Screw | Salvin Dental Specialties, Inc. | 2008 | — |
| 0 (this device) | K103084 | Neodent Graft Screw | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073342 | Salvin Dental Specialties, Inc., Fixation ScrewSummary page 2…is available in various lengths, thread diameters and head diameters. PREDICATE DEVICES Salvin Dental Specialties Fixation Screw from Salvin Dental Specialties, Inc. (K073342) STOMA Bone Block Screw, Steel from Storz am Mark GmbH (K080430) Bone Block Fixation Set from Straumann USA, Inc. (KO0O0515) TE… | 2008 |
| * | K080430 | Stoma Bone Block ScrewSummary page 2…ters. PREDICATE DEVICES Salvin Dental Specialties Fixation Screw from Salvin Dental Specialties, Inc. (K073342) STOMA Bone Block Screw, Steel from Storz am Mark GmbH (K080430) Bone Block Fixation Set from Straumann USA, Inc. (KO0O0515) TECHOLOGICAL CHARACTERISTICS The design, materials and functional… | 2008 |
| Kept off the family tree | K000515 | FDA’s K000515 is Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… Our reading of the summary gave K000515, FDA’s number for Pro Osteon 200R Resorbable Bone Graft Substitute, Models… (Interpore Cross Intl.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Bone Block Fixation Set”. Kept off the family tree. | 2000 |
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 35 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 20 ancestors has a recall of any class.
- 1 other device also cites its predicate K073342.
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?
This product is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103084: Neodent Graft Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103084
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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