510(k) · Cleared
ClearedProimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proimtech Saglik Urunleri Anonim Sirketi · DZE Implant, Endosseous, Root-Form
Cleared on Aug 23, 2024 as substantially equivalent to K140878 (Straumann USA, LLC, 2014) and 7 other predicates after a 493-day review. Its family tree reaches back 16 generations to 1996.
- Decided
- Aug 23, 2024
- Review
- 493 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 16 generations to K960026 (1996). 300 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations between
- 3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 2 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- This deviceK231100 Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing…Proimtech Saglik Urunleri Anonim Sirketi · 2024
Show all 16 generations
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 14 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 13 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 9 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 8 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 7 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 6 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 5 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 4 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 2 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- This deviceK231100 Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing…Proimtech Saglik Urunleri Anonim Sirketi · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −15 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −9 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −8 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −7 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −6 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −5 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −4 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −3 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −2 | K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −1 | K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018 | — |
| 0 (this device) | K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap… | Proimtech Saglik Urunleri Anonim Sirketi | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 14 | 0 |
| 1994 | 13 | 0 |
| 1995 | 12 | 0 |
| 1996 | 16 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 7 | 0 |
| 2001 | 16 | 0 |
| 2002 | 19 | 0 |
| 2003 | 19 | 0 |
| 2004 | 19 | 0 |
| 2005 | 10 | 0 |
| 2006 | 17 | 0 |
| 2007 | 19 | 0 |
| 2008 | 12 | 0 |
| 2009 | 12 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (8)
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 |
|---|---|---|---|
| * | K140878 | Straumann Bone Level Tapered ImplantSummary page 6…1 Legally Marketed Device to Which Claim Substantial Equivalence: for; Primary Predicate Device Implant Body: K140878, STRAUMANN BONE LEVEL TAPERED IMPLANT for; Reference Device Implant Body: K173961, Straumann® BLX Implant System for; Reference… | 2014 |
| * | K173961 | Straumann BLX Implant SystemSummary page 6…e to Which Claim Substantial Equivalence: for; Primary Predicate Device Implant Body: K140878, STRAUMANN BONE LEVEL TAPERED IMPLANT for; Reference Device Implant Body: K173961, Straumann® BLX Implant System for; Reference Device Implant Body: K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Im… | 2018 |
| * | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsSummary page 6…lant Body: K140878, STRAUMANN BONE LEVEL TAPERED IMPLANT for; Reference Device Implant Body: K173961, Straumann® BLX Implant System for; Reference Device Implant Body: K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants for; Reference Device Implant Body: K130222, Straumann Dental Implan… | 2022 |
| * | K130222 | Straumann Dental Implant SystemSummary page 6…raumann® BLX Implant System for; Reference Device Implant Body: K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants for; Reference Device Implant Body: K130222, Straumann Dental Implant System SLActive and Roxolid Product Families for; Reference Device Abutment: K160850, Nucleoss Abutmen… | 2013 |
| * | K160850 | Nucleoss Tpure Implant SystemSummary page 6…14 and L16) Implants for; Reference Device Implant Body: K130222, Straumann Dental Implant System SLActive and Roxolid Product Families for; Reference Device Abutment: K160850, Nucleoss Abutment System SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI for; Reference Device Abutment Screw: K182448, MegaGe… | 2017 |
| * | K182448 | AnyRidge Octa 1 Implant SystemSummary page 6…oduct Families for; Reference Device Abutment: K160850, Nucleoss Abutment System SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI for; Reference Device Abutment Screw: K182448, MegaGen Implant Co., Ltd. for; Reference Device Healing Cap: K052957, Dentium Implantium® & SuperLine® Prosthetics for; Refere… | 2019 |
| * | K052957 | Implantium ProstheticsSummary page 6…ent System SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI for; Reference Device Abutment Screw: K182448, MegaGen Implant Co., Ltd. for; Reference Device Healing Cap: K052957, Dentium Implantium® & SuperLine® Prosthetics for; Reference Healing Cap: K051636, CAMLOG Dental Implant Abutments, Healing Caps… | 2006 |
| * | K051636 | Camlog Dental Implant Abutments, Healing Caps, and AccessoriesSummary page 6…Abutment Screw: K182448, MegaGen Implant Co., Ltd. for; Reference Device Healing Cap: K052957, Dentium Implantium® & SuperLine® Prosthetics for; Reference Healing Cap: K051636, CAMLOG Dental Implant Abutments, Healing Caps, and Accessories 2… | 2006 |
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 28 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 40 of the 300 ancestors have a recall of any class.
- 8 other devices also cite its predicate K140878.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with…
Read the full statement (108 words)
Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Bilimplant Abutments and Prosthetic parts are intended for use with Bilimplant Dental Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231100 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231100: Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231100
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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