510(k) Report

510(k) · Cleared

Cleared

Camlog Dental Implant Abutments, Healing Caps, and Accessories

K051636510(k) AbbreviatedCleared Feb 17, 2006242-day reviewClass II21 CFR 872.3630

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

Altatec GmbH · NHA Abutment, Implant, Dental, Endosseous

Cleared on Feb 17, 2006 after a 242-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.

Decided
Feb 17, 2006
Review
242 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
0

19 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2024: 4 descendants cleared2011: 1 descendant cleared2010: 1 descendant cleared2018: 1 descendant cleared2012: 1 descendant cleared2016: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2015: 2 descendants cleared2022: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared2023: 2 descendants cleared20052010201520202025
  1. This deviceK051636 Camlog Dental Implant Abutments, Healing Caps, and AccessoriesAltatec GmbH · 2006
  2. Descendant · cites it directly · 14 of its ownK113779 Conelog Implant SystemAltatec GmbH · 2012
  3. Descendant · 2 generations on · 9 of its ownK193401 Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH · 2020
  4. Descendant · 2 generations on · 8 of its ownK203252 Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021
  5. Descendant · 3 generations on · 3 of its ownK213106 BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022
  6. Descendant · 2 generations on · 2 of its ownK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 12014: 12015: 22016: 12018: 12020: 12021: 12022: 12023: 22024: 42025: 12026: 1
2010high 4 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 19 · See all
  • K113779Conelog Implant SystemAltatec GmbH · 2012 · cites it directly14descendants
  • K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH · 2020 · 2 generations on9descendants
  • K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021 · 2 generations on8descendants
  • K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022 · 3 generations on3descendants
  • K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051636Camlog Dental Implant Abutments, Healing Caps, and AccessoriesAltatec GmbH2006—
+1K113779Conelog Implant SystemAltatec GmbH2012—
+2K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH2020—
+2K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.2021—
+3K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.2022—
+2K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201210
201410
201520
201610
201810
202010
202110
202210
202320
202440
202510
202610
FIG. 1 — Lineage of K051636, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 NHA? 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 NHA device

  1. #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Straumann Dental Implant System - Healing caps
Named without a submission number
—
*—Replace Select Implant System - Healing abutments
Named without a submission number
—
*—Straumann Dental Implant System - Retentive anchors
Named without a submission number
—
*—Replace Select Implant System - O-Ring abutments
Named without a submission number
—
*—Straumann Dental Implant System - Screw retained abutments
Named without a submission number
—
*—Replace Select Implant System - PME-Abutments
Named without a submission number
—
*—Healing Cap Item No. 2290
Named without a submission number
—
*—RN synOcta Gold Cap Item No. 048.632
Named without a submission number
—
*—PME Coping, Gold Item No. 2149
Named without a submission number
—

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K113779Conelog Implant SystemAltatec GmbH201214
K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240
K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180
K101890Ball Abutment SystemMegagen Co., Ltd.20110
K093975Simpler Toadstool Abutment, Model S19000-S19009Pan Global Implant20100

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, K113779 (Altatec GmbH, 2012) has gone furthest, with 14 descendants of its own.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

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

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

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

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

What is it indicated for?

CAMLOG implants are used to support dental prostheses in the upper and lower jaws. They may be used for functional and aesthetic oral restoration of partially edentulous and edentulous jaws using crowns, bridges, partial or complete prostheses, which are connected to CAMLOG implants using suitable components. CAMLOG BallAbutments support implant retained mucosa supported overdentures. CAMLOG Bar Abutments (including bases) support custom milled or…

Read the full statement (103 words)

CAMLOG implants are used to support dental prostheses in the upper and lower jaws.

They may be used for functional and aesthetic oral restoration of partially edentulous and edentulous jaws using crowns, bridges, partial or complete prostheses, which are connected to CAMLOG implants using suitable components.

CAMLOG BallAbutments support implant retained mucosa supported overdentures.

CAMLOG Bar Abutments (including bases) support custom milled or prefabricated bars for overdentures.

CAMLOG Healing Caps (Cylindrical, Wide Body, Bottleneck, bar and for Bar Abutment) displace the gingiva from the space above the CAMLOG implant or abutment during the CAMLOG implant healing time and serve for proper gingiva shaping.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K051636: Camlog Dental Implant Abutments, Healing Caps, and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051636

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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