510(k) · Cleared
ClearedDentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental Abutment System / Dentin Restoration S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentin Implants Technologies, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 5, 2012 as substantially equivalent to K063364 (Alpha-Bio Tec, Ltd., 2007) and 7 other predicates after a 134-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Jul 5, 2012
- Review
- 134 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 10 generations to K960026 (1996). 94 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 6 generations between
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- This deviceK120530 Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece…Dentin Implants Technologies, Ltd. · 2012
Show all 10 generations
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 8 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 7 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- This deviceK120530 Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece…Dentin Implants Technologies, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −9 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −3 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −2 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −1 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| 0 (this device) | K120530 | Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin… | Dentin Implants Technologies, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K063364 | Alpha Bio Dental Implant SystemSummary page 2…Vtl STERLING MEDICAL REGISTRIATION DENTIN® Dental Implants System is substantially equivalent to Alplha-Bio Tec K063364; MIS Implant Technologies Ltd K003191, K103089, K080162; NOBELREPLACE K023113, K062566; Implant Direct SwissPlant K081396 in… | 2007 |
| * | K003191 | Mis Implant System DeciveSummary page 2…Vtl STERLING MEDICAL REGISTRIATION DENTIN® Dental Implants System is substantially equivalent to Alplha-Bio Tec K063364; MIS Implant Technologies Ltd K003191, K103089, K080162; NOBELREPLACE K023113, K062566; Implant Direct SwissPlant K081396 in terms of intended use, indication… | 2001 |
| * | K103089 | Seven Implants; Biocom Implants; Lance ImplantsSummary page 2…Vtl STERLING MEDICAL REGISTRIATION DENTIN® Dental Implants System is substantially equivalent to Alplha-Bio Tec K063364; MIS Implant Technologies Ltd K003191, K103089, K080162; NOBELREPLACE K023113, K062566; Implant Direct SwissPlant K081396 in terms of intended use, indication for use,… | 2011 |
| * | K080162 | Uno - One Piece Screw-Type Dental ImplantSummary page 2…RLING MEDICAL REGISTRIATION DENTIN® Dental Implants System is substantially equivalent to Alplha-Bio Tec K063364; MIS Implant Technologies Ltd K003191, K103089, K080162; NOBELREPLACE K023113, K062566; Implant Direct SwissPlant K081396 in terms of intended use, indication for use, technolog… | 2008 |
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 2…N DENTIN® Dental Implants System is substantially equivalent to Alplha-Bio Tec K063364; MIS Implant Technologies Ltd K003191, K103089, K080162; NOBELREPLACE K023113, K062566; Implant Direct SwissPlant K081396 in terms of intended use, indication for use, technological characteristics,… | 2002 |
| * | K062566 | Nobelreplace Tapered Conical ConnectionSummary page 2…NTIN® Dental Implants System is substantially equivalent to Alplha-Bio Tec K063364; MIS Implant Technologies Ltd K003191, K103089, K080162; NOBELREPLACE K023113, K062566; Implant Direct SwissPlant K081396 in terms of intended use, indication for use, technological characteristics, performan… | 2006 |
| * | K081396 | Swissplant Dental Implant SystemSummary page 2…stantially equivalent to Alplha-Bio Tec K063364; MIS Implant Technologies Ltd K003191, K103089, K080162; NOBELREPLACE K023113, K062566; Implant Direct SwissPlant K081396 in terms of intended use, indication for use, technological characteristics, performance and user interface. DENTIN®… | 2009 |
| * | K090347 | Camlog Abutments PSSummary page 2…dication for use, technological characteristics, performance and user interface. DENTIN® PEEK Abutments are substantially equivalent to; CAMLOG® Abutments PS K090347 in terms of intended use, indication for use, technological characteristics, performance and user interface. The predicat… | 2009 |
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 3 companies; a new generation was cleared every 9 months on median.
- 13 of the 94 ancestors have a recall of any class.
- 12 other devices also cite its predicate K063364.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
DENTIN® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. DENTIN® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: CLASSIC, RAPID…
Read the full statement (103 words)
DENTIN® Dental Implants System is indicated for use in surgical and restorative
applications for placement in the bone of the upper or lower jaw to provide support for
prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
DENTIN® Dental Implants System is indicated also for immediate loading when good
primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: CLASSIC, RAPID, PRESTIGE.
One Stage Implants: ONE PIECE
DENTIN® ONEPIECE Implants 3.0 mmd are intended for placement at the mandibular
central and lateral incisors and maxillary and lateral incisors. Indicated also for denture
stabilization using multiple implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120530: Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental Abutment System / Dentin Restoration S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120530
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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