510(k) Report

510(k) · Cleared

Cleared

Camlog Implant System Modified Implants and Abutments

K083496510(k) TraditionalCleared Jan 30, 200966-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Altatec GmbH · DZE Implant, Endosseous, Root-Form

Cleared on Jan 30, 2009 after a 66-day review. The FDA summary names no predicate by number. 266 later devices descend from it.

Decided
Jan 30, 2009
Review
66 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

266 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2011: 5 descendants cleared2015: 8 descendants cleared2016: 15 descendants cleared2012: 3 descendants cleared2014: 6 descendants cleared2017: 13 descendants cleared2013: 5 descendants cleared2021: 15 descendants cleared2024: 36 descendants cleared2020: 24 descendants cleared2019: 16 descendants cleared2018: 11 descendants cleared2022: 25 descendants cleared2023: 30 descendants cleared2025: 34 descendants cleared2026: 20 descendants cleared20052010201520202025
  1. This deviceK083496 Camlog Implant System Modified Implants and AbutmentsAltatec GmbH · 2009
  2. Descendant · cites it directly · 201 of its ownK111287 Astra Tech Implant SystemAstra Tech AB · 2011
  3. Descendant · 2 generations on · 200 of its ownK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
  4. Descendant · cites it directly · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
  5. Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
  6. Descendant · cites it directly · 83 of its ownK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011

Showing 5 of 266 descendants. See all descendants

Descendants cleared per year

2011: 52012: 32013: 52014: 62015: 82016: 152017: 132018: 112019: 162020: 242021: 152022: 252023: 302024: 362025: 342026: 20
2011high 36 (2024) · low 3 (2012)2026

Most influential descendants

Showing 5 of 266 · See all
  • K111287Astra Tech Implant SystemAstra Tech AB · 2011 · cites it directly201descendants
  • K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011 · 2 generations on200descendants
  • K120414Osseospeed PlusAstra Tech AB · 2012 · cites it directly196descendants
  • K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
  • K102804Spi Titanium Base for Cad/CamThommen Medical AG · 2011 · cites it directly83descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083496Camlog Implant System Modified Implants and AbutmentsAltatec GmbH2009—
+1K111287Astra Tech Implant SystemAstra Tech AB2011—
+2K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011—
+1K120414Osseospeed PlusAstra Tech AB2012—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL2017—
+1K102804Spi Titanium Base for Cad/CamThommen Medical AG2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201150
201230
201350
201460
201580
2016150
2017130
2018110
2019160
2020240
2021150
2022250
2023300
2024360
2025340
2026200
FIG. 1 — Lineage of K083496, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (266)

See all 266

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111287Astra Tech Implant SystemAstra Tech AB2011201
K120414Osseospeed PlusAstra Tech AB2012196
K102804Spi Titanium Base for Cad/CamThommen Medical AG201183
K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.201145
K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130
K113779Conelog Implant SystemAltatec GmbH201214
K132881Z5CZ-Systems AG20148
K142167Medentika Abutment SystemMedentika GmbH20157
K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154
K133991ISYAltatec GmbH20142

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?

  • Of its descendants, K111287 (Astra Tech AB, 2011) has gone furthest, with 201 descendants of its own.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

Camlog Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Camlog 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.

Indications for use as stated in the FDA summary.

More from Altatec GmbH

14 FDA decisions under this applicant name. See the company

  • K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH · 2020
  • K160784CAM Titanium BlanksAltatec GmbH · 2016
  • K153779Abutment for BridgesAltatec GmbH · 2016
  • K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH · 2016
  • K151599iSy Implant SystemAltatec GmbH · 2015

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K083496 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083496: Camlog Implant System Modified Implants and Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083496

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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