510(k) · Cleared
ClearedProvata Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Implants (Pty), Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 6, 2023 as substantially equivalent to K180282 (Mis Implants Technologies, Ltd., 2018) and 4 other predicates after a 203-day review. Its family tree reaches back 15 generations to 1993.
- Decided
- Mar 6, 2023
- Review
- 203 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K925765 (1993). 286 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 15 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 11 generations between
- 3 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 2 generations backK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- 1 generation backK180465 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018
- This deviceK222457 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023
Show all 15 generations
- Root · 15 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 14 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 13 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 12 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 11 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 10 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 9 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 8 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 7 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 6 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 5 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 4 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 3 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 2 generations backK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- 1 generation backK180465 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018
- This deviceK222457 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −14 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −13 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −12 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −11 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −10 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −9 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −8 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −7 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −6 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −5 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| −4 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| −3 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| −2 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| −1 | K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| 0 (this device) | K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 6 | 0 |
| 1990 | 8 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 15 | 0 |
| 1994 | 13 | 0 |
| 1995 | 15 | 0 |
| 1996 | 14 | 0 |
| 1997 | 10 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 5 | 0 |
| 2001 | 15 | 0 |
| 2002 | 16 | 0 |
| 2003 | 11 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 14 | 0 |
| 2007 | 15 | 0 |
| 2008 | 11 | 0 |
| 2009 | 12 | 0 |
| 2010 | 8 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K180282 | MIS Internal Hex Dental Implant SystemSummary page 5…Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary predicate devices: K180282, MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd. Reference devices: K163634, External Hex Implants… | 2018 |
| * | K163634 | External Hex ImplantsSummary page 5…REDICATE DEVICE INFORMATION Primary predicate devices: K180282, MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd. Reference devices: K163634, External Hex Implants, Southern Implants (Pty) Ltd. K180465, Provata Implant System, Southern Implants (Pty) Ltd.… | 2017 |
| * | K180465 | Provata Implant SystemSummary page 5…2, MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd. Reference devices: K163634, External Hex Implants, Southern Implants (Pty) Ltd. K180465, Provata Implant System, Southern Implants (Pty) Ltd. K191250, Southern Implants PEEK abutments, Southern Implants (Pty)… | 2018 |
| * | K191250 | Southern Implants PEEK AbutmentsSummary page 5…td. Reference devices: K163634, External Hex Implants, Southern Implants (Pty) Ltd. K180465, Provata Implant System, Southern Implants (Pty) Ltd. K191250, Southern Implants PEEK abutments, Southern Implants (Pty) Ltd. K193084, TIB Abutment System, Southern Implants (Pty) Ltd… | 2019 |
| * | K193084 | TIB Abutment SystemSummary page 5…(Pty) Ltd. K180465, Provata Implant System, Southern Implants (Pty) Ltd. K191250, Southern Implants PEEK abutments, Southern Implants (Pty) Ltd. K193084, TIB Abutment System, Southern Implants (Pty) Ltd. K151455, 3Shape Abutment Designer K130991, SageMax NexxZr Zirc… | 2020 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K130991 | Nexxzr (TM)T and Nexxzr (TM)S | 2014 |
| † | K130436 | Multilink Hybrid Abutment Cement | 2013 |
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 30 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 35 of the 286 ancestors have a recall of any class.
- 6 other devices also cite its predicate K180282.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Indications for Use for the Provata Implants: The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved. The intended use for the 03.30 Provata implants is limited to…
Read the full statement (298 words)
Indications for Use for the Provata Implants:
The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved. The intended use for the 03.30 Provata implants is limited to replacement of maxillary and mandibular lateral and central incisors. The 12° angled Co-Axis Provata Implants are intended to only be used with straight abutments.
Indications for Use for the TIB Abutments:
The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Indications for Use for the Conventional Abutments and Prosthetic Screws:
The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous or partially edentulous maxilla and/or mandible to provide support for crowns, bridges or overdentures.
Indications for Use for the PEEK Temporary Abutments:
The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Indications for Use for the Temporary Titanium Abutments:
The Southern Implants Temporary Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222457: Provata 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/K222457
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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