510(k) · Cleared
ClearedTatum Surgical Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suncoast Dental, Inc. Dba Tatum Surgical · DZE Implant, Endosseous, Root-Form
Cleared on Jul 15, 2022 as substantially equivalent to K133510 (Jj Industria E Comercio DE Materiais Dentarios SA, 2014) and 12 other predicates after a 247-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.
- Decided
- Jul 15, 2022
- Review
- 247 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 13 generations to K960026 (1996). 221 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations between
- 3 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 2 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 1 generation backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- This deviceK213576 Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022
- Descendant · cites it directly · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
Show all 13 generations
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 11 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 10 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 6 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 5 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 4 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 3 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 2 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 1 generation backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- This deviceK213576 Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022
Most influential descendants
Showing 1 of 1 · See all- K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −12 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −6 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −5 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −4 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −3 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −2 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −1 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| 0 (this device) | K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | 2022 | — |
| +1 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
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 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 12 | 0 |
| 1994 | 9 | 0 |
| 1995 | 12 | 0 |
| 1996 | 12 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 8 | 0 |
| 2001 | 15 | 0 |
| 2002 | 15 | 0 |
| 2003 | 14 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2006 | 10 | 0 |
| 2007 | 14 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (13)
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 |
|---|---|---|---|
| * | K133510 | Neodent Implant SystemSummary page 4…NHA Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device K133510, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA. Additional Predicate Devices K102034, Blue Sky Bio… | 2014 |
| * | K102034 | Blue Sky Bio Dental Implant SystemSummary page 4…REDICATE DEVICE INFORMATION Primary Predicate Device K133510, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA. Additional Predicate Devices K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K180282, MIS Internal Hex Dental Implant System, MIS Implants Technologies… | 2011 |
| * | K180282 | MIS Internal Hex Dental Implant SystemSummary page 4…Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA. Additional Predicate Devices K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K180282, MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd 510(k) Summary… | 2018 |
| * | K122231 | Xpeed Any Ridge Internal Implant SystemSummary page 5…Tatum Surgical Dental Implant System Page 2 of 13 K213576 K122231, Xpeed AnyRidge Internal Implant System, MegaGen Implant K061410, Zimmer Dental (Advent) Implant System, Zimmer Dental, Inc. K122… | 2012 |
| * | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Summary page 5…tem Page 2 of 13 K213576 K122231, Xpeed AnyRidge Internal Implant System, MegaGen Implant K061410, Zimmer Dental (Advent) Implant System, Zimmer Dental, Inc. K122231, Xpeed AnyRidge Internal Implant System, MegaGen Implant K111… | 2006 |
| * | K111581 | 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Summary page 5…rnal Implant System, MegaGen Implant K061410, Zimmer Dental (Advent) Implant System, Zimmer Dental, Inc. K122231, Xpeed AnyRidge Internal Implant System, MegaGen Implant K111581, NobelActive 3.0 Angled Abutment, Nobel Biocare USA, LLC K092035, Bicon Implants with 2.5 mm Internal Connection, Bicon LLC K1717… | 2011 |
| * | K092035 | Bicon Implants with a 2.5MM Internal ConnectionSummary page 5…nt) Implant System, Zimmer Dental, Inc. K122231, Xpeed AnyRidge Internal Implant System, MegaGen Implant K111581, NobelActive 3.0 Angled Abutment, Nobel Biocare USA, LLC K092035, Bicon Implants with 2.5 mm Internal Connection, Bicon LLC K171728, MOR Implant, Sterngold K071235, K063523, K052997, Zimmer One-… | 2009 |
| * | K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSummary page 5…ernal Implant System, MegaGen Implant K111581, NobelActive 3.0 Angled Abutment, Nobel Biocare USA, LLC K092035, Bicon Implants with 2.5 mm Internal Connection, Bicon LLC K171728, MOR Implant, Sterngold K071235, K063523, K052997, Zimmer One-Piece Implant, Zimmer Dental K093595, CeraRoot Implant System, Oral… | 2017 |
| * | K071235 | Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13Summary page 5…plant K111581, NobelActive 3.0 Angled Abutment, Nobel Biocare USA, LLC K092035, Bicon Implants with 2.5 mm Internal Connection, Bicon LLC K171728, MOR Implant, Sterngold K071235, K063523, K052997, Zimmer One-Piece Implant, Zimmer Dental K093595, CeraRoot Implant System, Oral Iceberg S.L. K110548, Juell OSI… | 2007 |
| * | K063523 | Zimmer One Piece Implant, 3.7MM and 4.7MM, Models ZOP37S10, 11, 13, 16; ZOP37A10, 11…Summary page 5…1581, NobelActive 3.0 Angled Abutment, Nobel Biocare USA, LLC K092035, Bicon Implants with 2.5 mm Internal Connection, Bicon LLC K171728, MOR Implant, Sterngold K071235, K063523, K052997, Zimmer One-Piece Implant, Zimmer Dental K093595, CeraRoot Implant System, Oral Iceberg S.L. K110548, Juell OSI O-ball A… | 2007 |
| * | K052997 | Zimmer Dental One-Piece ImplantSummary page 5…elActive 3.0 Angled Abutment, Nobel Biocare USA, LLC K092035, Bicon Implants with 2.5 mm Internal Connection, Bicon LLC K171728, MOR Implant, Sterngold K071235, K063523, K052997, Zimmer One-Piece Implant, Zimmer Dental K093595, CeraRoot Implant System, Oral Iceberg S.L. K110548, Juell OSI O-ball Abutment D… | 2006 |
| * | K093595 | Ceraroot Implant SystemSummary page 5…LLC K092035, Bicon Implants with 2.5 mm Internal Connection, Bicon LLC K171728, MOR Implant, Sterngold K071235, K063523, K052997, Zimmer One-Piece Implant, Zimmer Dental K093595, CeraRoot Implant System, Oral Iceberg S.L. K110548, Juell OSI O-ball Abutment Dental Implant, Juell Dental INDICATIONS FOR USE… | 2011 |
| * | K110548 | Osi O-Ball Abutment Head ImplantsSummary page 5…nection, Bicon LLC K171728, MOR Implant, Sterngold K071235, K063523, K052997, Zimmer One-Piece Implant, Zimmer Dental K093595, CeraRoot Implant System, Oral Iceberg S.L. K110548, Juell OSI O-ball Abutment Dental Implant, Juell Dental INDICATIONS FOR USE STATEMENT The Tatum Surgical Integrity Tapered, “T… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | 2026 | 0 |
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 26 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 29 of the 221 ancestors have a recall of any class.
- Of its descendants, K254145 (Smart Denture Conversions, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K133510.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Tatum Surgical Integrity Tapered, “T” and “S” Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prothesis to restore chewing function. It may be used with single-stage or two- stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Tatum Surgical…
Read the full statement (213 words)
The Tatum Surgical Integrity Tapered, “T” and “S” Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prothesis to restore chewing function. It may be used with single-stage or two- stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The Tatum Surgical Dental “P” Plateau Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unit restorations and is indicated for delayed loading, placed with conventional two-stage surgical process with secondary and transmucosal healing.
The Tatum Surgical One-Piece Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter Tatum Surgical One-Piece Implant must be splinted if two or more are used adjacent to each other.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213576: Tatum Surgical 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/K213576
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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