510(k) · Cleared
ClearedPiezoImplant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rex Implants, Inc. · NRQ Blade-Form Endosseous Dental Implant
Cleared on Oct 12, 2022 as substantially equivalent to K133049 (Biomet 3i, 2014) after a 482-day review. Its family tree reaches back 13 generations to 1993.
- Decided
- Oct 12, 2022
- Review
- 482 days
- Class
- Class II
- Product code
- NRQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K925765 (1993). 70 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 13 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 9 generations between
- 3 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 2 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 1 generation backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- This deviceK211872 PiezoImplant SystemRex Implants, Inc. · 2022
Show all 13 generations
- Root · 13 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 12 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 11 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 10 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 9 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 8 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 7 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 6 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 5 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 4 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 3 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 2 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 1 generation backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- This deviceK211872 PiezoImplant SystemRex Implants, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −12 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −11 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −10 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −9 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −8 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −7 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −6 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −5 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −4 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −3 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| −2 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| −1 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| 0 (this device) | K211872 | PiezoImplant System | Rex Implants, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2007 | 2 | 0 |
| 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 NRQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K133049 | 3I T3(R) External Hex Dental ImplantsSummary page 4…screws are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. Primary Predicate: Biomet 3i T3 (Biomet 3i™, K133049) Reference devices: Startanius™ NRI (Park Dental Research Corp., K854749). Published clinical result… | 2014 |
| † | K854749 | Startanius Dental Implant System | 1986 |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
| † | K032158 | Xive Dental Implant System Multiple | 2003 |
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 29 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 12 of the 70 ancestors have a recall of any class.
- 3 other devices also cite its predicate K133049.
How does its category compare?
All NRQ devicesNRQ Blade-Form Endosseous Dental Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NRQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NRQ
Too few NRQ 510(k)s in any year since 2007 to give a median.
Recalls per year · NRQ
No recall names NRQ since 2007.
Adverse event reports per year · NRQ
No MAUDE report names NRQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Piezolmplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate adult patients over the age of 21 in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The Piezolmplant System is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211872 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211872: PiezoImplant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211872
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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