510(k) Report

510(k) · Cleared

Cleared

Auradapt Aubtment System

K972475510(k) TraditionalCleared Sep 12, 199773-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

Nobel Biocare Uas, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Sep 12, 1997 as substantially equivalent to K934495 (Nobelpharma AB, 1994) and 9 other predicates after a 73-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.

Decided
Sep 12, 1997
Review
73 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
12

Its longest line of descent runs back 3 generations to K944964 (1995). 18 ancestors in all, the oldest K910611 (1991). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 3 other ancestors1994: 2 other ancestors1993: 8 other ancestors1991: 1 other ancestor2008: 1 descendant cleared2011: 1 descendant clearedK944964 · Branemark System Miruscone Abutment System · Nobelpharma USA, Inc. · 1995×2: 2 generations cleared close together, K961728 (1996), K962403 (1996) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 6 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K962403 · Noblepharma Wide Accessories · Nobelpharma USA, Inc. · 1996K961728 · Miruscone Abutment System · Nobelpharma USA, Inc. · 1996K944964 · Branemark System Miruscone Abutment System · Nobelpharma USA, Inc. · 19950
  1. Root · 3 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
  2. 2 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
  3. 1 generation backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
  4. This deviceK972475 Auradapt Aubtment SystemNobel Biocare Uas, Inc. · 1997
  5. Descendant · cites it directly · 1 of its ownK083100 Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging…Nobel Biocare USA, LLC · 2008
  6. Descendant · 2 generations on · 0 of its ownK112259 Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC · 2008 · cites it directly1descendant
  • K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K944964Branemark System Miruscone Abutment SystemNobelpharma USA, Inc.1995—
−2K961728Miruscone Abutment SystemNobelpharma USA, Inc.1996—
−1K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc.1996—
0 (this device)K972475Auradapt Aubtment SystemNobel Biocare Uas, Inc.1997—
+1K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP…Nobel Biocare USA, LLC2008—
+2K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199380
199420
199530
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
FIG. 1 — Lineage of K972475, 1995–2011Source: 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 30.7 · 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? (13)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K934495Branemark System (R) Ucla-Type Abutment Complete
Summary page 1
…The Predicate Product The predicate products used in this Pre-market Notification are similar components marketed by Nobel Biocare including the UCLA - Type Abutments (K934495), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device…
Nobelpharma AB1994—
*K961737Cera One Abutment System
Summary page 1
…te products used in this Pre-market Notification are similar components marketed by Nobel Biocare including the UCLA - Type Abutments (K934495), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), EsthetiCone Temporary Cy…
Nobelpharma USA, Inc.1996—
Kept off the family treeK911969Guide Pin
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…his Pre-market Notification are similar components marketed by Nobel Biocare including the UCLA - Type Abutments (K934495), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), EsthetiCone Temporary Cylinder (K925766), Mir…
*K925769Branemark System Abutments Complete
Summary page 1
…e similar components marketed by Nobel Biocare including the UCLA - Type Abutments (K934495), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), EsthetiCone Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K96…
Nobelpharma USA, Inc.1993—
*K953775Brandemark Accessories to Ceramic Abutyment (Ceramicore)
Summary page 1
…ding the UCLA - Type Abutments (K934495), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), EsthetiCone Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K962403), Temporary Tube (K926766), Titanium Impression…
Nobelpharma USA, Inc.1995—
*K925766Branemark System Temporary Solutions
Summary page 1
…CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), EsthetiCone Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K962403), Temporary Tube (K926766), Titanium Impression Coping (K952448), Plastic Impression Copi…
Nobelpharma USA, Inc.1994—
*K962403Noblepharma Wide Accessories
Summary page 1
…Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), EsthetiCone Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K962403), Temporary Tube (K926766), Titanium Impression Coping (K952448), Plastic Impression Coping (K910611), CeraOne™ Screwdrivers (K92…
Nobelpharma USA, Inc.1996—
Kept off the family treeK926766Temporary Tube
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…ab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), EsthetiCone Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K962403), Temporary Tube (K926766), Titanium Impression Coping (K952448), Plastic Impression Coping (K910611), CeraOne™ Screwdrivers (K922805) and Fixture Guide Se…
*K9524483.3MM Accessories
Summary page 1
…Counter Torque Device (K953775), EsthetiCone Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K962403), Temporary Tube (K926766), Titanium Impression Coping (K952448), Plastic Impression Coping (K910611), CeraOne™ Screwdrivers (K922805) and Fixture Guide Set Tray (K944963). D. Description of D…
Nobelpharma USA, Inc.1995—
*K910611Nobelpharma Ceraone Abutment System
Summary page 1
…hetiCone Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K962403), Temporary Tube (K926766), Titanium Impression Coping (K952448), Plastic Impression Coping (K910611), CeraOne™ Screwdrivers (K922805) and Fixture Guide Set Tray (K944963). D. Description of Device The Nobe! Biocare AurAdapt™ Ab…
Nobelpharma USA, Inc.1991—
*K922805Nobelpharma Torque Controller
Summary page 1
…766), Miruscone Temporary Cylinder (K962403), Temporary Tube (K926766), Titanium Impression Coping (K952448), Plastic Impression Coping (K910611), CeraOne™ Screwdrivers (K922805) and Fixture Guide Set Tray (K944963). D. Description of Device The Nobe! Biocare AurAdapt™ Abutment System is a set of modifia…
Nobelpharma USA, Inc.1993—
*K944963Branemark System Smiline II
Summary page 1
…962403), Temporary Tube (K926766), Titanium Impression Coping (K952448), Plastic Impression Coping (K910611), CeraOne™ Screwdrivers (K922805) and Fixture Guide Set Tray (K944963). D. Description of Device The Nobe! Biocare AurAdapt™ Abutment System is a set of modifiable gold alloy abutments which are se…
Nobelpharma USA, Inc.1995—
*—CerAdapt™
Named without a submission number
—

Also cleared against K934495: 9 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081

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 2 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
  • None of the 18 ancestors has a recall.
  • Of its descendants, K083100 (Nobel Biocare USA, LLC, 2008) has gone furthest, with 1 descendant of its own.
  • 9 other devices also cite its predicate K934495.

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?

Nobel Biocare’s AurAdapt Abutment System is a set of screw retained modifiable gold alloy abutments which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient’s chewing function.

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 K934495

9 other devices cite the same predicate.

  • K961385MT-3AThe Emerging Technologies Group · 1996
  • K961387MT-XThe Emerging Technologies Group · 1996
  • K961384MT-2The Emerging Technologies Group · 1996
  • K961386MT-2AThe Emerging Technologies Group · 1996
  • K961383MT1The Emerging Technologies Group · 1996
  • K961382MT1AThe Emerging Technologies Group · 1996

More from Nobel Biocare Uas, Inc.

31 FDA decisions under this applicant name. See the company

  • K050444Nobelreplace Adapter, Model 32412Nobel Biocare Uas, Inc. · 2005
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004
  • K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
  • K041876Nobeldirect OD ImplantNobel Biocare Uas, Inc. · 2004
  • K041312Nobelrondo Dental Ceramic-AluminaNobel Biocare Uas, Inc. · 2004

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/K972475 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972475: Auradapt Aubtment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972475

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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