510(k) · Cleared
ClearedImplant-One System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Dental Implants, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 10, 2011 as substantially equivalent to K063341 (Implant Innovations, Inc., 2007) and 4 other predicates after a 104-day review. Its family tree reaches back 9 generations to 1993. 3 later devices descend from it.
- Decided
- Jan 10, 2011
- Review
- 104 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K925765 (1993). 82 ancestors in all, the oldest K781060 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- This deviceK102822 Implant-One SystemCustom Dental Implants, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK173701 Implant-One SystemImplant Logistics, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK230242 OsteoCentric Dental Implant SystemOsteoCentric Technologies · 2023
- Descendant · cites it directly · 0 of its ownK141159 Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh · 2015
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- This deviceK102822 Implant-One SystemCustom Dental Implants, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K173701Implant-One SystemImplant Logistics, Inc. · 2018 · cites it directly1descendant
- K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies · 2023 · 2 generations on0descendants
- K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| 0 (this device) | K102822 | Implant-One System | Custom Dental Implants, Inc. | 2011 | — |
| +1 | K173701 | Implant-One System | Implant Logistics, Inc. | 2018 | — |
| +2 | K230242 | OsteoCentric Dental Implant System | OsteoCentric Technologies | 2023 | — |
| +1 | K141159 | Konus Dental Implant System | Argon Med. Productions Vertriebs Gesellschaft Mbh | 2015 | — |
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 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 1…Ti-6A1-4V) as described by ASTM F1472 or stainless steel according to ASTM A582. Predicate Devices: Biomet 3i dental implants and abutments (K063341/K072642) Zimmer Screw Vent and Contour Abutment (K061 41 0/K061 847) FRIADENT Imp… | 2007 |
| * | K072642 | Biomet 3I Dental Abutments and Restorative ComponentsSummary page 1…V) as described by ASTM F1472 or stainless steel according to ASTM A582. Predicate Devices: Biomet 3i dental implants and abutments (K063341/K072642) Zimmer Screw Vent and Contour Abutment (K061 41 0/K061 847) FRIADENT Implant Sys… | 2007 |
| * | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Summary page 1…according to ASTM A582. Predicate Devices: Biomet 3i dental implants and abutments (K063341/K072642) Zimmer Screw Vent and Contour Abutment (K061 41 0/K061 847) FRIADENT Implant Systems (K073075)… | 2006 |
| * | K061847 | Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S, ZRA452SSummary page 1…to ASTM A582. Predicate Devices: Biomet 3i dental implants and abutments (K063341/K072642) Zimmer Screw Vent and Contour Abutment (K061 41 0/K061 847) FRIADENT Implant Systems (K073075)… | 2006 |
| * | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsSummary page 1…nts and abutments (K063341/K072642) Zimmer Screw Vent and Contour Abutment (K061 41 0/K061 847) FRIADENT Implant Systems (K073075) Page 9 Technological… | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 months on median.
- 15 of the 82 ancestors have a recall of any class.
- Of its descendants, K173701 (Implant Logistics, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 14 other devices also cite its predicate K063341.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Implant-One system is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102822: Implant-One System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102822
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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