510(k) Report

510(k) · Cleared

Cleared

CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)

K152509510(k) TraditionalCleared Jan 12, 2016132-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 Jan 12, 2016 as substantially equivalent to K133421 (Straumann USA, LLC, 2014) and 1 other predicate after a 132-day review. Its family tree reaches back 11 generations to 1990.

Decided
Jan 12, 2016
Review
132 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
2

Its longest line of descent runs back 11 generations to K894595 (1990). 72 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors2007: 2 other ancestors1999: 2 other ancestors2010: 1 other ancestor2006: 2 other ancestors2005: 2 other ancestors2004: 5 other ancestors2003: 4 other ancestors2002: 8 other ancestors2001: 7 other ancestors2000: 2 other ancestors1996: 8 other ancestors1995: 2 other ancestors1990: 2 other ancestors1994: 3 other ancestors1993: 4 other ancestors1992: 2 other ancestors1997: 2 other ancestors1998: 1 other ancestorReference device: K073553 · Camlog Implant System Abutments · Altatec GmbH · 2008Reference device: K083496 · Camlog Implant System Modified Implants and Abutments · Altatec GmbH · 2009Reference device: K113779 · Conelog Implant System · Altatec GmbH · 2012K894595 · Bonefit R Screw Implants · Institut Straumann AG · 1990K984104 · Iti Dental Implant System · Straumann USA · 1999 · recalledK992937 · Dental Implant · Nobel Biocare Uas, Inc. · 2000 · recalled×2: 2 generations cleared close together, K013067 (2002), K021318 (2002) K032158 · Xive Dental Implant System Multiple · Friadent GmbH · 2003K041509 · Ankylos Dental Implant System · Friadent GmbH · 2004K083805 · Ankylos C/X Dental Implant System · Dentsply Intl., Inc. · 2009K101945 · Neodent Implant System · Jjgc Industria E Comercio DE Materiais Dentarios S · 2011K133421 · Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw · Straumann USA, LLC · 2014K141871 · Straumann Bone Level NC Angled Screw Retained Abutments · Straumann USA, LLC · 2014199019952000200520102015
  1. Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
  2. 7 generations between
  3. 3 generations backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
  4. 2 generations backK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
  5. 1 generation backK141871 Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC · 2014
  6. This deviceK152509 CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH · 2016
Show all 11 generations
  1. Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
  2. 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
  3. 9 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
  4. 8 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
  5. 7 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
  6. 6 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
  7. 5 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
  8. 4 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
  9. 3 generations backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
  10. 2 generations backK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
  11. 1 generation backK141871 Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC · 2014
  12. This deviceK152509 CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K894595Bonefit R Screw ImplantsInstitut Straumann AG1990—
−10K984104Iti Dental Implant SystemStraumann USA19991
−9K992937Dental ImplantNobel Biocare Uas, Inc.20001
−8K013067Frialoc Dental Implant SystemFriadent GmbH2002—
−7K021318Xive Dental Implant SystemFriadent GmbH2002—
−6K032158Xive Dental Implant System MultipleFriadent GmbH2003—
−5K041509Ankylos Dental Implant SystemFriadent GmbH2004—
−4K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc.2009—
−3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011—
−2K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold…Straumann USA, LLC2014—
−1K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC2014—
0 (this device)K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199220
199340
199430
199520
199680
199720
199810
199920
200020
200170
200280
200340
200450
200520
200620
200720
200820
201010
FIG. 1 — Lineage of K152509, 1990–2016Source: 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 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? (2)

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
*K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw
Summary page 5
…OG® and CONELOG® ASR Page 2 of 4 K152509 PREDICATE INFORMATION The primary predicate device is K133421. Reference Predicates K141871 - Straumann® Screw Retained Abutments K073553 - CAMLOG Implant System Abutments K083496 - CAMLOG I…
Straumann USA, LLC2014—
*K141871Straumann Bone Level NC Angled Screw Retained Abutments
Summary page 5
…4 K152509 PREDICATE INFORMATION The primary predicate device is K133421. Reference Predicates K141871 - Straumann® Screw Retained Abutments K073553 - CAMLOG Implant System Abutments K083496 - CAMLOG Implant System Modified Implants…
Straumann USA, LLC2014—
†K073553Camlog Implant System AbutmentsAltatec GmbH2008—
†K083496Camlog Implant System Modified Implants and AbutmentsAltatec GmbH2009—
†K113779Conelog Implant SystemAltatec GmbH2012—

Also cleared against K133421: 9 other devices →

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 26 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
  • 5 of the 72 ancestors have a recall of any class.
  • 9 other devices also cite its predicate K133421.

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. 2016, this device’s year, is highlighted.

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® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw-retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K152509: CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152509

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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