510(k) · Cleared
ClearedQuantum Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantum Bioengineering, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 13, 2013 as substantially equivalent to K112279 (Quantum Bioengineering, Ltd., 2012) and 3 other predicates after an 84-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Jun 13, 2013
- Review
- 84 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K894595 (1990). 45 ancestors in all, the oldest K820013 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 2 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 1 generation backK112279 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012
- This deviceK130787 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 6 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 5 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 4 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 3 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 2 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 1 generation backK112279 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012
- This deviceK130787 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −6 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −5 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −3 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −2 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −1 | K112279 | Quantum Dental Implant System | Quantum Bioengineering, Ltd. | 2012 | — |
| 0 (this device) | K130787 | Quantum Dental Implant System | Quantum Bioengineering, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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? (5)
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 |
|---|---|---|---|
| * | K112279 | Quantum Dental Implant SystemSummary page 2…ndications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: . K112279 - Quantum BioEngineering, Ltd., Quantum™ Dental Implant System K00224] - Quantum BioEngineering, Ltd., Quantum™ Versatility Dent… | 2012 |
| Kept off the family tree | K002241 | FDA’s K002241 is Quantum Versatility (QVS) Dental Implant System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K991250 | Quantum Versatility Implant SystemSummary page 2…nt devices: . K112279 - Quantum BioEngineering, Ltd., Quantum™ Dental Implant System K00224] - Quantum BioEngineering, Ltd., Quantum™ Versatility Dental Implant System K991250 - Quantum BioEngineering, Ltd., Quantum Versatility™ Implant System K101849 - Bicon, LLC, Bicon Dental Implant System 3.0mm K101… | 2001 |
| * | K101849 | Bicon Dental Implant System 3.0MM Bicon Dental ImplantSummary page 2…nt System K00224] - Quantum BioEngineering, Ltd., Quantum™ Versatility Dental Implant System K991250 - Quantum BioEngineering, Ltd., Quantum Versatility™ Implant System K101849 - Bicon, LLC, Bicon Dental Implant System 3.0mm K101732 - Astra Tech AB, Astra Tech Implant System The subject device and the p… | 2010 |
| * | K101732 | Astra Tech Implant SystemSummary page 2…m™ Versatility Dental Implant System K991250 - Quantum BioEngineering, Ltd., Quantum Versatility™ Implant System K101849 - Bicon, LLC, Bicon Dental Implant System 3.0mm K101732 - Astra Tech AB, Astra Tech Implant System The subject device and the predicate devices have the same intended use and have the… | 2011 |
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 23 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 45 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implants may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants. The @3.0 mm Quantum Dental Implant is limited to replacement of maxillary lateral incisors and mandibular central and lateral incisors.
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/K130787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130787: Quantum Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130787
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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