510(k) · Cleared
ClearedBioline Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioline Dental Implant Systems, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 18, 2025 as substantially equivalent to K240837 (Rdj Tov Implant, Ltd., 2024) after an 86-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Jun 18, 2025
- Review
- 86 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894595 (1990). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK170372 SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc. · 2017
- 2 generations backK182293 OsseOne Dental Implant SystemSynoross Dba Osseone · 2019
- 1 generation backK240837 TOV Dental Implant SystemRdj Tov Implant, Ltd. · 2024
- This deviceK250872 Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 7 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 6 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 5 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 4 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 3 generations backK170372 SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc. · 2017
- 2 generations backK182293 OsseOne Dental Implant SystemSynoross Dba Osseone · 2019
- 1 generation backK240837 TOV Dental Implant SystemRdj Tov Implant, Ltd. · 2024
- This deviceK250872 Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −7 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −5 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −4 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −3 | K170372 | SpiralTech Dental Implant System | Spiraltech Superior Dental Implants, Inc. | 2017 | — |
| −2 | K182293 | OsseOne Dental Implant System | Synoross Dba Osseone | 2019 | — |
| −1 | K240837 | TOV Dental Implant System | Rdj Tov Implant, Ltd. | 2024 | — |
| 0 (this device) | K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K240837 | TOV Dental Implant SystemSummary page 8…r Safety in the Magnetic Resonance (MR) Environment,” including magnetically induced displacement force and torque. Primary Predicate Device: TOV Dental Implant System K240837 Substantial Equivalence: The Bioline Dental Implant System is substantially equivalent to TOV Dental Implants in indications for… | 2024 |
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 35 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 25 ancestors have a recall of any class.
- 3 other devices also cite its predicate K240837.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Bioline Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Charanga, Bolero and DACA are intended for immediate loading when good primary stability is…
Read the full statement (128 words)
The Bioline Dental Implant System are endosseous implants intended to be surgically placed in the
upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in
order to restore patient's esthetics and chewing function. Implants are intended for single or multiple
unit restorations on splinted or non-splinted applications. Charanga, Bolero and DACA are intended
for immediate loading when good primary stability is achieved, and with appropriate occlusive
loading. These implants can also be used for loading after a conventional healing period. Bolero 3.3
implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in
the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3
implants adjacent to one another.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250872: Bioline 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/K250872
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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