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 May 4, 2012 as substantially equivalent to K011223 (Paxmed International, 2001) and 6 other predicates after a 269-day review. Its family tree reaches back 9 generations to 1990. 1 later device descends from it.
- Decided
- May 4, 2012
- Review
- 269 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K894595 (1990). 43 ancestors in all, the oldest K820013 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- This deviceK112279 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK130787 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- This deviceK112279 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −1 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| 0 (this device) | K112279 | Quantum Dental Implant System | Quantum Bioengineering, Ltd. | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (7)
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 |
|---|---|---|---|
| * | K011223 | Quantum Versatility (QVS) Dental Implant System | 2001 |
| * | K002241 | Quantum Versatility (QVS) Dental Implant SystemSummary page 2…QuantumnTM Versatility Dental Implant System, cleared under KO 1223, Quantum BioEngineering, Ltd., QuantumTm Versatility Dental Implant System, cleared under K002241, Quantum BioEngineering, Ltd., Quantum VersatilityTM Implant System, cleared under K991250, Bicon, LLC., Bicon Implan… | 2001 |
| * | K991250 | Quantum Versatility Implant SystemSummary page 2…, Ltd., QuantumTm Versatility Dental Implant System, cleared under K002241, Quantum BioEngineering, Ltd., Quantum VersatilityTM Implant System, cleared under K991250, Bicon, LLC., Bicon Implants with a 2.Smm Internal Connection, cleared under K092035, Bicon, Inc., 4.5 x 6.0mmn and 6.0 x… | 2001 |
| * | K092035 | Bicon Implants with a 2.5MM Internal ConnectionSummary page 2…um BioEngineering, Ltd., Quantum VersatilityTM Implant System, cleared under K991250, Bicon, LLC., Bicon Implants with a 2.Smm Internal Connection, cleared under K092035, Bicon, Inc., 4.5 x 6.0mmn and 6.0 x 6.0mmn Dental Implant, cleared under K050712, Bicon, Inc., 6.0 x 5.7mm Dental Implan… | 2009 |
| * | K050712 | 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental ImplantSummary page 2…50, Bicon, LLC., Bicon Implants with a 2.Smm Internal Connection, cleared under K092035, Bicon, Inc., 4.5 x 6.0mmn and 6.0 x 6.0mmn Dental Implant, cleared under K050712, Bicon, Inc., 6.0 x 5.7mm Dental Implant, cleared under KOl10i18, and Astra Tech AB, Astra Tech Implant System, cleared u… | 2005 |
| * | K010185 | 6.0 X 5.7MM Dental ImplantSummary page 3…same as the predicates KOl 1223, K002241 and K991250. The subject device implant largest diameter and shortest lengths are the same as the predicates K092035, K0507 12, K010185 and K101732. The subject and predicate devices are packaged in similar materials and sterilized using similar methods, or provid… | 2002 |
| * | K101732 | Astra Tech Implant SystemSummary page 2…ntal Implant, cleared under K050712, Bicon, Inc., 6.0 x 5.7mm Dental Implant, cleared under KOl10i18, and Astra Tech AB, Astra Tech Implant System, cleared under K101732. Page 12 of 13 === Page 3 ==… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130787 | Quantum Dental Implant System | 2013 | 0 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 43 ancestors have a recall of any class.
- Of its descendants, K130787 (Quantum Bioengineering, Ltd., 2013) has gone furthest, with 0 descendants of its own.
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?
Quantum TM, Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Quantum Dental Implant System abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implant 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, or when using any 5 mm or 6 mm length implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112279: 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/K112279
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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