510(k) · Cleared
ClearedEndosseous Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Implants, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 22, 2008 as substantially equivalent to K033171 (Northern Implants, LLC, 2004) and 2 other predicates after a 101-day review. Its family tree reaches back 7 generations to 1990. 14 later devices descend from it.
- Decided
- Dec 22, 2008
- Review
- 101 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K894595 (1990). 47 ancestors in all, the oldest K874590 (1988). 14 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 4 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
- 2 generations backK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
- 1 generation backK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
- This deviceK082651 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2008
- Descendant · cites it directly · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 2 generations on · 2 of its ownK180465 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK231967 ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · cites it directly13descendants
- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 2 generations on3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 2 generations on2descendants
- K180465Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018 · 2 generations on2descendants
- K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −4 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K024004 | Xive Transgingival Dental Implant System | Friadent GmbH | 2003 | — |
| −2 | K033171 | Nsi Hexed and Non-Hexed Implant System and Immediate Loading | Northern Implants, LLC | 2004 | — |
| −1 | K052490 | Endosseous Dental Implant System | Northern Implants, LLC | 2005 | — |
| 0 (this device) | K082651 | Endosseous Dental Implant System | Southern Implants, Inc. | 2008 | — |
| +1 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +2 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +2 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +2 | K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| +2 | K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1993 | 10 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K033171 | Nsi Hexed and Non-Hexed Implant System and Immediate LoadingSummary page 1…ndards. Southern Implants screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV titanium. Predicate Devices: K033171 5.0mm and .6.0mm 120 Co-Axis K052490 4.0mm 12° Co-Axis K970499 Branemark Sy… | 2004 |
| * | K052490 | Endosseous Dental Implant SystemSummary page 1…nts are manufactured from ASTM F67-95 Grade III or Grade IV titanium. Predicate Devices: K033171 5.0mm and .6.0mm 120 Co-Axis K052490 4.0mm 12° Co-Axis K970499 Branemark System Zygomatic Implant Device Description and Intended Use: The… | 2005 |
| * | K970499 | Branemark System Zygomaticus Fixture SystemSummary page 1…Grade IV titanium. Predicate Devices: K033171 5.0mm and .6.0mm 120 Co-Axis K052490 4.0mm 12° Co-Axis K970499 Branemark System Zygomatic Implant Device Description and Intended Use: The 240 Co-Axis implant is intended to be implanted in th… | 1997 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163634 | External Hex Implants | 2017 | 13 |
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 6 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 47 ancestors have a recall of any class.
- Of its descendants, K163634 (Southern Implants (Pty), Ltd., 2017) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K033171.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
This implant is not intended, nor should it be used, in conjunction with an angled abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082651: Endosseous 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/K082651
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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