510(k) · Cleared
ClearedTitan Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titan Implants, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 14, 2005 as substantially equivalent to K031632 (Implant Innovations, Inc., 2003) and 15 other predicates after a 78-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jan 14, 2005
- Review
- 78 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 16
Its longest line of descent runs back 6 generations to K925765 (1993). 45 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 4 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 3 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 2 generations backK031632 Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc. · 2003
- 1 generation backK033430 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685…Implant Innovations, Inc. · 2003
- This deviceK042971 Titan Dental Implant SystemTitan Implants, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −5 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −4 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −3 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −2 | K031632 | Osseotite Iol Implants and Osseotite Certain Iol Implants | Implant Innovations, Inc. | 2003 | — |
| −1 | K033430 | 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610… | Implant Innovations, Inc. | 2003 | — |
| 0 (this device) | K042971 | Titan Dental Implant System | Titan Implants, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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? (16)
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 |
|---|---|---|---|
| * | K031632 | Osseotite Iol Implants and Osseotite Certain Iol ImplantsSummary page 3…ally equivalent in indications and design principles to the following predicate devices: * Implant Innovations Osseofite Implants cleared on September 16, 2003 under K031632 hImplant Innovations TG Osseofite Inplants cleared November 7, 2003 under K033430 * Bicon Dental Implant II cleared A… | 2003 |
| * | K033430 | 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611…Summary page 3…* Implant Innovations Osseofite Implants cleared on September 16, 2003 under K031632 hImplant Innovations TG Osseofite Inplants cleared November 7, 2003 under K033430 * Bicon Dental Implant II cleared August 18, 1997 under K972029 · Bicon Dental Implant 11 4.5 mm cleared January 11, 2000… | 2003 |
| * | K972029 | Bicon Dental Implants II Part Abutment SystemSummary page 3…2003 under K031632 hImplant Innovations TG Osseofite Inplants cleared November 7, 2003 under K033430 * Bicon Dental Implant II cleared August 18, 1997 under K972029 · Bicon Dental Implant 11 4.5 mm cleared January 11, 2000 under K994037 * Bicon Dental Implant I1 6.0 x 5.7 mm cleared De… | 1997 |
| * | K994037 | The 4.5MM Diameter Bicon Dental ImplantSummary page 3…ed November 7, 2003 under K033430 * Bicon Dental Implant II cleared August 18, 1997 under K972029 · Bicon Dental Implant 11 4.5 mm cleared January 11, 2000 under K994037 * Bicon Dental Implant I1 6.0 x 5.7 mm cleared December 30, 2002 under K010185 * BioHorizons Maestro Dental Implant clear… | 2000 |
| * | K010185 | 6.0 X 5.7MM Dental ImplantSummary page 3…1997 under K972029 · Bicon Dental Implant 11 4.5 mm cleared January 11, 2000 under K994037 * Bicon Dental Implant I1 6.0 x 5.7 mm cleared December 30, 2002 under K010185 * BioHorizons Maestro Dental Implant cleared September 16, 1997 under K972313 * BioHorizons Maestro Dental Implant cleare… | 2002 |
| * | K972313 | The Maestro SystemSummary page 3…nder K994037 * Bicon Dental Implant I1 6.0 x 5.7 mm cleared December 30, 2002 under K010185 * BioHorizons Maestro Dental Implant cleared September 16, 1997 under K972313 * BioHorizons Maestro Dental Implant cleared May 16, 2001 under K010458 * Frialit-2 Dental Implant cleared March 24, 2000… | 1997 |
| * | K010458 | The Maestro SystemSummary page 3…2002 under K010185 * BioHorizons Maestro Dental Implant cleared September 16, 1997 under K972313 * BioHorizons Maestro Dental Implant cleared May 16, 2001 under K010458 * Frialit-2 Dental Implant cleared March 24, 2000 under K994376 • Friadent XiVE Dental Implant cleared July 2, 2002 under… | 2001 |
| * | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped…Summary page 3…September 16, 1997 under K972313 * BioHorizons Maestro Dental Implant cleared May 16, 2001 under K010458 * Frialit-2 Dental Implant cleared March 24, 2000 under K994376 • Friadent XiVE Dental Implant cleared July 2, 2002 under K0213 18 * INNOVA Endopore Dental Implant cleared October 2, 20… | 2000 |
| * | K021318 | Xive Dental Implant SystemSummary page 3…lant cleared May 16, 2001 under K010458 * Frialit-2 Dental Implant cleared March 24, 2000 under K994376 • Friadent XiVE Dental Implant cleared July 2, 2002 under K0213 18 * INNOVA Endopore Dental Implant cleared October 2, 2003 under K032140 · INNOVA Endopore Dental Implant April 9, 2004 und… | 2002 |
| * | K032140 | 5.0 X 5MM Endopore Endosseous Dental Implant SystemSummary page 3…ed March 24, 2000 under K994376 • Friadent XiVE Dental Implant cleared July 2, 2002 under K0213 18 * INNOVA Endopore Dental Implant cleared October 2, 2003 under K032140 · INNOVA Endopore Dental Implant April 9, 2004 under K040714 · Lifecore Dental Implant cleared May 16, 2001 under K002037… | 2003 |
| * | K040714 | Hybrid Endopore Endosseous Dental ImplantSummary page 3…t cleared July 2, 2002 under K0213 18 * INNOVA Endopore Dental Implant cleared October 2, 2003 under K032140 · INNOVA Endopore Dental Implant April 9, 2004 under K040714 · Lifecore Dental Implant cleared May 16, 2001 under K002037 * SteriOss (now Nobel Biocare) Replace Tapered Implant clear… | 2004 |
| * | K002037 | Lifecore Biomedical Dental Implant SystemsSummary page 3…l Implant cleared October 2, 2003 under K032140 · INNOVA Endopore Dental Implant April 9, 2004 under K040714 · Lifecore Dental Implant cleared May 16, 2001 under K002037 * SteriOss (now Nobel Biocare) Replace Tapered Implant cleared March 5, 1997 under K964220 * SteriOss (now Nobel… | 2001 |
| * | K964220 | Replace Titanium Implant SystemSummary page 3…r K040714 · Lifecore Dental Implant cleared May 16, 2001 under K002037 * SteriOss (now Nobel Biocare) Replace Tapered Implant cleared March 5, 1997 under K964220 * SteriOss (now Nobel Biocare) Replace Cylindrical Implant cleared March 16, 1998 under K980439 * Straumann ITI… | 1997 |
| * | K980439 | Replace Cylindrical ImplantsSummary page 3…Replace Tapered Implant cleared March 5, 1997 under K964220 * SteriOss (now Nobel Biocare) Replace Cylindrical Implant cleared March 16, 1998 under K980439 * Straumann ITI Dental Implant System cleared March 31, 2003 under K030007 * Astra Tech Dental Implant System cleared Fe… | 1998 |
| * | K030007 | Iti Dental Implant SystemSummary page 3…iOss (now Nobel Biocare) Replace Cylindrical Implant cleared March 16, 1998 under K980439 * Straumann ITI Dental Implant System cleared March 31, 2003 under K030007 * Astra Tech Dental Implant System cleared February 8, 1994 under K931767. The TITAN Dental Implant System has the followin… | 2003 |
| * | K931767 | Astra Tech Implants-Dental SystemSummary page 3…1998 under K980439 * Straumann ITI Dental Implant System cleared March 31, 2003 under K030007 * Astra Tech Dental Implant System cleared February 8, 1994 under K931767. The TITAN Dental Implant System has the following similarities to the predicate devices: * has the same intended use,… | 1994 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 45 ancestors have a recall of any class.
- 6 other devices also cite its predicate K031632.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2007high 61 (2008) · low 26 (2011)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
2007high 265 (2014) · low 107 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
2007high 15 (2016) · low 0 (2011)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
2007high 537,585 (2023) · low 164 (2009)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 TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042971: Titan 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/K042971
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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