510(k) · Cleared
ClearedPitt-Easy Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Implant Solutions GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Jan 28, 2009 as substantially equivalent to K053242 (Innova Life Sciences Corp., 2006) after a 79-day review. Its family tree reaches back 3 generations to 1991. 84 later devices descend from it.
- Decided
- Jan 28, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902435 (1991). 19 ancestors in all, the oldest K820013 (1982). 84 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK902435 Dia Impression CopingDental Imaging Assoc., Inc. · 1991
- 2 generations backK961385 MT-3AThe Emerging Technologies Group · 1996
- 1 generation backK053242 Pitt-Easy Dental Implant SystemInnova Life Sciences Corp. · 2006
- This deviceK083297 Pitt-Easy Dental Implant SystemSybron Implant Solutions GmbH · 2009
- Descendant · cites it directly · 83 of its ownK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
- Descendant · 2 generations on · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · 2 generations on · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- Descendant · 3 generations on · 29 of its ownK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K102804Spi Titanium Base for Cad/CamThommen Medical AG · 2011 · cites it directly83descendants
- K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · 2 generations on45descendants
- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 3 generations on36descendants
- K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · 2 generations on30descendants
- K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902435 | Dia Impression Coping | Dental Imaging Assoc., Inc. | 1991 | — |
| −2 | K961385 | MT-3A | The Emerging Technologies Group | 1996 | — |
| −1 | K053242 | Pitt-Easy Dental Implant System | Innova Life Sciences Corp. | 2006 | — |
| 0 (this device) | K083297 | Pitt-Easy Dental Implant System | Sybron Implant Solutions GmbH | 2009 | — |
| +1 | K102804 | Spi Titanium Base for Cad/Cam | Thommen Medical AG | 2011 | — |
| +2 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| +3 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +2 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| +3 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K053242 | Pitt-Easy Dental Implant SystemSummary page 1…ant, Endosseous Dental, per 21 CFR § 872.3640 Devices for Which Substantial Equivalence is Claimed: · Sybron Implant Solutions GmbH, Pitt-Easy/ DentalImplant System, K053242 Device Description: The Pitt-Easy Dental Implant System is an endosseous dental implant that is intended to be surgically place… | 2006 |
What descends from it? (84)
See all 841 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102804 | Spi Titanium Base for Cad/Cam | 2011 | 83 |
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 18 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K102804 (Thommen Medical AG, 2011) has gone furthest, with 83 descendants of its own.
- 1 other device also cites its predicate K053242.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083297: Pitt-Easy Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083297
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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