510(k) · Cleared
ClearedConelog Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altatec GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Dec 14, 2012 as substantially equivalent to K083496 (Altatec GmbH, 2009) and 6 other predicates after a 358-day review. Its family tree reaches back 9 generations to 1993. 14 later devices descend from it.
- Decided
- Dec 14, 2012
- Review
- 358 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K925765 (1993). 126 ancestors in all, the oldest K781060 (1978). 14 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- This deviceK113779 Conelog Implant SystemAltatec GmbH · 2012
- Descendant · cites it directly · 9 of its ownK193401 Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH · 2020
- Descendant · cites it directly · 8 of its ownK203252 Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK213106 BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022
- Descendant · cites it directly · 2 of its ownK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK231827 BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- This deviceK113779 Conelog Implant SystemAltatec GmbH · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH · 2020 · cites it directly9descendants
- K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021 · cites it directly8descendants
- K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022 · 2 generations on3descendants
- K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024 · cites it directly2descendants
- K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| 0 (this device) | K113779 | Conelog Implant System | Altatec GmbH | 2012 | — |
| +1 | K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | Altatec GmbH | 2020 | — |
| +1 | K203252 | Multi-unit Abutments for CONELOG | BioHorizons Implant Systems, Inc. | 2021 | — |
| +2 | K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2022 | — |
| +1 | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024 | — |
| +3 | K231827 | BTI Dental Implant System UnicCa® – Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. | 2023 | — |
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 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 9 | 0 |
| 1994 | 9 | 0 |
| 1995 | 11 | 0 |
| 1996 | 11 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K083496 | Camlog Implant System Modified Implants and AbutmentsSummary page 3…equivalent in indications and design principles to the following predicate devices: Altatec GmnbH, CAMLOG Implant System Modified Implants and Abutments cleared under K083496; Altatec GmbH, CAMLOG' VarioSR Abutments cleared under K103252; Altatec GmbH, Altatec CAMLOG Abutments and Healing Caps clear… | 2009 |
| * | K103252 | Camlog Vario SR AbutmentsSummary page 3…predicate devices: Altatec GmnbH, CAMLOG Implant System Modified Implants and Abutments cleared under K083496; Altatec GmbH, CAMLOG' VarioSR Abutments cleared under K103252; Altatec GmbH, Altatec CAMLOG Abutments and Healing Caps cleared under K05 1636; Astra Tech, Inc., OsseoSpeedTM 4.OS - 6 mm c… | 2011 |
| * | K051636 | Camlog Dental Implant Abutments, Healing Caps, and AccessoriesSummary page 3…Abutments cleared under K083496; Altatec GmbH, CAMLOG' VarioSR Abutments cleared under K103252; Altatec GmbH, Altatec CAMLOG Abutments and Healing Caps cleared under K05 1636; Astra Tech, Inc., OsseoSpeedTM 4.OS - 6 mm cleared under K063779, Sulzer Dental, Inc., Screw-Vent Dental Implant System clea… | 2006 |
| * | K063779 | Osseospeed 4.0S-6MM, Model 24619Summary page 3…ments cleared under K103252; Altatec GmbH, Altatec CAMLOG Abutments and Healing Caps cleared under K05 1636; Astra Tech, Inc., OsseoSpeedTM 4.OS - 6 mm cleared under K063779, Sulzer Dental, Inc., Screw-Vent Dental Implant System cleared under KOl 1028, Implant Innovations, Inc., OSSEOTITE® Certain®… | 2007 |
| * | K011028 | Screw-Vent Dental Implant System | 2001 |
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 3…r K063779, Sulzer Dental, Inc., Screw-Vent Dental Implant System cleared under KOl 1028, Implant Innovations, Inc., OSSEOTITE® Certain® Dental Implants cleared under K063341, Bicon, LLC., 03.0 x 8 mm and 03.0 x I I mmr Bicon Implant 3.0mm cleared under K101 849. The CONELOG Implant System is an addi… | 2007 |
| * | K101849 | Bicon Dental Implant System 3.0MM Bicon Dental ImplantSummary page 3…, Implant Innovations, Inc., OSSEOTITE® Certain® Dental Implants cleared under K063341, Bicon, LLC., 03.0 x 8 mm and 03.0 x I I mmr Bicon Implant 3.0mm cleared under K101 849. The CONELOG Implant System is an additional implant line to the CAMLOG Implant System using a tapered implant/abutment interfac… | 2010 |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 14 of the 126 ancestors have a recall of any class.
- Of its descendants, K193401 (Altatec GmbH, 2020) has gone furthest, with 9 descendants of its own.
- 11 other devices also cite its predicate K083496.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
CONELOG Implant System Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. CONELOG Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. CONELOG Implants with 3.3 mm diameter have the following…
Read the full statement (387 words)
CONELOG Implant System Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. CONELOG Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
CONELOG Implants with 3.3 mm diameter have the following additional specific indications:
These are an alternative in cases where the alveolar ridge width is only 5 - 6 mm. Because of their lower mechanical strength compared with larger diameter implants, they should only be used under the following conditions:
* As single implants, they should be used only to replace mandibular incisors and/or maxillary lateral incisors.
* An edentulous arch can only be restored with a bar retained superstructure with at least four implants of 3.3 mm diameter without distal extensions.
* Implants of 0 3.3 mm are suitable for a partially edentulous arch when combined with implants of larger diameter for splinted superstructures. However, the limited strength of the implants with 0 3.3 mm must be taken into account.
* Avoid excessive mechanical stressing of the implants when using ball abutments in combination with 0 3.3 mm implants.
* The healing time for 0 3.3 mm implants is at least 12 weeks.
CONELOG Implants with 7 mm length have the following additional specific indications:
CONELOG SCREW-LINE Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.
CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.
CONELOG Vario SR components for crown and bridge restorations:
Occlusal screw-retained crown, bridge and bar constructions on CONELOG implants in the anterior and posterior region of the maxilla and mandible
CONELOG Vario SR components for bar restorations:
Anchorage of implant-supported full dentures for the edentulous maxilla in conjunction with 4 or more CONELOG implants and in the edentulous mandible in conjunction with 2 or 4 or more CONELOG implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113779: Conelog 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/K113779
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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