510(k) · Cleared
ClearedPeriotype X-Pert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical House Europe GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Apr 26, 2013 as substantially equivalent to K050406 (Nobel Biocare AB, 2005) and 4 other predicates after a 175-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it.
- Decided
- Apr 26, 2013
- Review
- 175 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K894595 (1990). 28 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- 1 generation backK111581 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment…Nobel Biocare AB · 2011
- This deviceK123386 Periotype X-PertClinical House Europe GmbH · 2013
- Descendant · cites it directly · 0 of its ownK151169 OsteoReady ZircoSeal AbutmentsOsteoready, LLC · 2015
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 backK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- 1 generation backK111581 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment…Nobel Biocare AB · 2011
- This deviceK123386 Periotype X-PertClinical House Europe GmbH · 2013
Most influential descendants
Showing 1 of 1 · See all- K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC · 2015 · cites it directly0descendants
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 | K102436 | Nobel Active 3.0 | Nobel Biocare AB | 2010 | — |
| −1 | K111581 | 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive… | Nobel Biocare AB | 2011 | — |
| 0 (this device) | K123386 | Periotype X-Pert | Clinical House Europe GmbH | 2013 | — |
| +1 | K151169 | OsteoReady ZircoSeal Abutments | Osteoready, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050406 | Nobelspeedy ImplantsSummary page 1…the implant: Nobel Biocare USA ILLO NOBELSPEEDY IMPLANTS K050406 Predicate Device for abutment: Nobel Estehtik Abutments… | 2005 |
| * | K111581 | 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Summary page 1…K050406 Predicate Device for abutment: Nobel Estehtik Abutments K111581 Branemark Systemn 17' angulated… | 2011 |
| * | K944962 | Branemark System 17 Angulated AbutmentSummary page 1…K111581 Branemark Systemn 17' angulated K944962 Branemark System Ball Attachment… | 1995 |
| * | K920452 | The Branemark System Ball Attachment Abutment SystSummary page 1…Branemark System Ball Attachment Abutment Syst K920452 Branemark System Titanium Healing Revision 0.0… | 1993 |
| * | K925779 | Branemark System Titanium Healing AbutmentsSummary page 2…510O(k) Summary Abutments K925779 Intended Use: PerioType X-Pert Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to… | 1993 |
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 |
|---|---|---|---|
| K151169 | OsteoReady ZircoSeal Abutments | 2015 | 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 23 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 28 ancestors have a recall of any class.
- Of its descendants, K151169 (Osteoready, LLC, 2015) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K050406.
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?
PerioType X-Pert Implants are threaded, root-form dental implants Intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients.
PerioType X-Pert Dental Implant Systems are indicated for delayed loading.
The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction With the PerioType X-Pert dental implant fixture to aid in prosthetic rehabilitation.
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/K123386 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123386: Periotype X-Pert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123386
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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