510(k) Report

510(k) · Cleared

Cleared

Anatotemp Anatomic Dental Implant Healing Abutment

K171922510(k) TraditionalCleared Sep 28, 201793-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

Buckeye Medical Technologies, LLC · NHA Abutment, Implant, Dental, Endosseous

Cleared on Sep 28, 2017 as substantially equivalent to K112099 (Contour Healer, LLC, 2012) after a 93-day review. Its family tree reaches back 2 generations to 2009.

Decided
Sep 28, 2017
Review
93 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K092377 (2009). No later device cites it as a predicate yet.

Reference device: K073033 · Legacy Dental Implants · Implant Direct, LLC · 2007Reference device: K080713 · Reactive Dental Implant System · Implant Direct, LLC · 2008Reference device: K073161 · Replus Dental Implants (HA) · Implant Direct, LLC · 2008Reference device: K061319 · Spectra System · Implant Direct, LLC · 2006 · recalledReference device: K130572 · Interactive/ SWISHPLUS2 Implant System · Implant Direct Sybron Manufacturing, LLC · 2013 · recalledReference device: K143011 · 2014 InterActive/SwishActive System · Implant Direct Sybron Manufacturing, LLC · 2015Reference device: K102034 · Blue Sky Bio Dental Implant System · Blue Sky Bio, LLC · 2011K092377 · Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S · Zimmer Dental, Inc. · 2009K112099 · Contour Healer · Contour Healer, LLC · 20122006200820102012201420162018
K112099 · Contour Healer · Contour Healer, LLC · 2012K092377 · Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S · Zimmer Dental, Inc. · 20090
  1. Root · 2 generations backK092377 Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A…Zimmer Dental, Inc. · 2009
  2. 1 generation backK112099 Contour HealerContour Healer, LLC · 2012
  3. This deviceK171922 Anatotemp Anatomic Dental Implant Healing AbutmentBuckeye Medical Technologies, LLC · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K092377Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S…Zimmer Dental, Inc.2009—
−1K112099Contour HealerContour Healer, LLC2012—
0 (this device)K171922Anatotemp Anatomic Dental Implant Healing AbutmentBuckeye Medical Technologies, LLC2017—
FIG. 1 — Lineage of K171922, 2009–2017Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K112099Contour Healer
Summary page 4
…: Class II Regulation Number: 21 CFR 872.3630 Product Code: NHA III. PREDICATE DEVICE Predicate: Contour Healer (K112099) Reference Predicates: Legacy Dental Implants (K073033) ReActive Dental Implant System (K080713) RePlus Dental Implants (K073161)…
Contour Healer, LLC2012—
†K073033Legacy Dental ImplantsImplant Direct, LLC2007—
†K080713Reactive Dental Implant SystemImplant Direct, LLC2008—
†K073161Replus Dental Implants (HA)Implant Direct, LLC2008—
†K061319Spectra SystemImplant Direct, LLC20064
†K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC20134
†K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC2015—
†K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC2011—

Also cleared against K112099: 1 other device →

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 8 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K112099.

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. 2017, 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?

The Anatotemp Anatomic Dental Implant Healing Abutment is a pre-manufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period. The single use, sterilized device is used by dental professionals during the dental implant healing process and is removed prior to permanent…

Read the full statement (137 words)

The Anatotemp Anatomic Dental Implant Healing Abutment is a pre-manufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period. The single use, sterilized device is used by dental professionals during the dental implant healing process and is removed prior to permanent prosthetic placement.

Anatotemp Anatomic Dental Implant Healing Abutments are compatible with the following implant systems:

Implant Direct Legacy — 3.5mmD, 4.5mmD, 5.7mmD

Implant Direct ReActive — 3.5mmD, 4.3mmD, 5.0mmD

Implant Direct RePlus — 3.5mmD, 4.3mmD, 5.0mmD

Implant Direct RePlant — 3.5mmD, 4.3mmD, 5.0mmD, 6.0mmD

Implant Direct SwishPlus — 4.8mmD, 6.5mmD

Implant Direct InterActive — 3.0mmD, 3.4mmD

Implant Direct SwishActive — 3.0mmD, 3.4mmD

Blue Sky Bio Quattro — Regular Platform (RP)

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K112099

1 other device cites the same predicate.

  • K120793Z-LOOK3 Evo SLMZ-Systems AG · 2012

Recent decisions in NHA

The NHA category page

  • K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2026
  • K262207Cemented Plus AbutmentUnidental Co., Ltd. · 2026
  • K260940BellaTek BarsZimVie US Corp, LLC · 2026
  • K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment…Nobel Biocare AB · 2026
  • K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026

https://510kreport.com/device/K171922 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171922: Anatotemp Anatomic Dental Implant Healing Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171922

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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