510(k) Report

510(k) · Cleared

Cleared

Tiadapt Abutment System

K971706510(k) TraditionalCleared Jul 21, 199774-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 Jul 21, 1997 as substantially equivalent to K910611 (Nobelpharma USA, Inc., 1991) and 9 other predicates after a 74-day review. Its family tree reaches back 3 generations to 1995. 545 later devices descend from it.

Decided
Jul 21, 1997
Review
74 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). 545 later devices descend from it, 5 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 ancestor2006: 7 descendants cleared2004: 6 descendants cleared2005: 4 descendants cleared1998: 1 descendant cleared2008: 6 descendants cleared2015: 27 descendants cleared2013: 15 descendants cleared2009: 14 descendants cleared2007: 5 descendants cleared2016: 33 descendants cleared2011: 14 descendants cleared2014: 21 descendants cleared2010: 9 descendants cleared2012: 14 descendants cleared2018: 27 descendants cleared2020: 42 descendants cleared2023: 45 descendants cleared2017: 26 descendants cleared2024: 60 descendants cleared2019: 24 descendants cleared2025: 43 descendants cleared2021: 39 descendants cleared2022: 37 descendants cleared2026: 26 descendants 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: 5 descendants2 generations forward: 14 descendants3 generations forward: 30 descendants4 generations forward: 66 descendants5 generations forward: 104 descendants6 generations forward: 93 descendants7 generations forward: 76 descendants8 generations forward: 54 descendants9 generations forward: 37 descendants10 generations forward: 27 descendants11 generations forward: 25 descendants12 generations forward: 8 descendants13 generations forward: 4 descendants14 generations forward: 1 descendant15 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+5+10+15
  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 deviceK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
  5. Descendant · cites it directly · 543 of its ownK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
  6. Descendant · 2 generations on · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  7. Descendant · 2 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  8. Descendant · 3 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
  9. Descendant · 4 generations on · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009

Showing 5 of 545 descendants. See all descendants

Descendants cleared per year

1998: 12004: 62005: 42006: 72007: 52008: 62009: 142010: 92011: 142012: 142013: 152014: 212015: 272016: 332017: 262018: 272019: 242020: 422021: 392022: 372023: 452024: 602025: 432026: 26
1998high 60 (2024) · low 0 (1999)2026

Most influential descendants

Showing 5 of 545 · See all
  • K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · cites it directly543descendants
  • K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · 2 generations on476descendants
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 2 generations on441descendants
  • K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 3 generations on327descendants
  • K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · 4 generations on313descendants
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)K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc.1997—
+1K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc.19982
+2K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.20041
+2K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
+3K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004—
+4K090069Procera Implant Bridge OverdentureNobel Biocare AB2009—

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
199810
200460
200540
200670
200750
200860
2009140
201090
2011140
2012140
2013150
2014210
2015270
2016330
2017260
2018270
2019240
2020420
2021390
2022370
2023450
2024600
2025430
2026260
FIG. 1 — Lineage of K971706, 1995–2026Source: 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 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? (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
*K910611Nobelpharma Ceraone Abutment System
Summary page 1
…C. The Predicate Product The predicate products used in this Pre-market Notification are similar components marketed by Nobel Biocare including the CeraOne Abutments (K910611), Ceramic Abutment (K913255), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Ma…
Nobelpharma USA, Inc.1991—
*K913255Ceramic (TM) Abutment
Summary page 1
…The predicate products used in this Pre-market Notification are similar components marketed by Nobel Biocare including the CeraOne Abutments (K910611), Ceramic Abutment (K913255), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device…
Ceramic Core Corp.1994—
*K961737Cera One Abutment System
Summary page 1
…Pre-market Notification are similar components marketed by Nobel Biocare including the CeraOne Abutments (K910611), Ceramic Abutment (K913255), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), Estheticone™ Temporary C…
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
…ion are similar components marketed by Nobel Biocare including the CeraOne Abutments (K910611), Ceramic Abutment (K913255), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), Estheticone™ Temporary Cylinder (K925766), Mi…
*K925769Branemark System Abutments Complete
Summary page 1
…keted by Nobel Biocare including the CeraOne Abutments (K910611), Ceramic Abutment (K913255), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), Estheticone™ Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K9…
Nobelpharma USA, Inc.1993—
*K953775Brandemark Accessories to Ceramic Abutyment (Ceramicore)
Summary page 1
…ts (K910611), Ceramic Abutment (K913255), 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 Impressio…
Nobelpharma USA, Inc.1995—
*K925766Branemark System Temporary Solutions
Summary page 1
…eraOne™ 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
…b-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—
*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 Nobel Biocare TiAdapt™ Abutment System is comprised of prep…
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 Nobel Biocare TiAdapt™ Abutment System is comprised of preparable titanium abutments which are s…
Nobelpharma USA, Inc.1995—
*—CerAdapt
Named without a submission number
—

Also cleared against K910611: 4 other devices →

What descends from it? (545)

See all 545

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

NumberDeviceApplicantDecidedDescendants
K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc.1998543
K041655Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd.200491
K052369Exfeel Implant SystemMegagen Co., Ltd.200684
K041275Procera Abutment OctagonNobel Biocare Uas, Inc.200461
K050635Allfim Implant SystemsCowellmedi Co., Ltd.20055

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 10 months on median.
  • None of the 18 ancestors has a recall.
  • Of its descendants, K974150 (Nobel Biocare Uas, Inc., 1998) has gone furthest, with 543 descendants of its own.
  • 4 other devices also cite its predicate K910611.

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 TiAdapt Abutment System is a set of screw retained preparable 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 K910611

4 other devices cite the same predicate.

  • K032562Proceara Copings and PonticNobel Biocare AB · 2004
  • K993894Lifecore Single Tooth Abutment SystemLifecore Biomedical, Inc. · 2000
  • K972475Auradapt Aubtment SystemNobel Biocare Uas, Inc. · 1997
  • K961737Cera One Abutment SystemNobelpharma USA, Inc. · 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/K971706 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971706: Tiadapt Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971706

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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