510(k) Report

510(k) · Cleared

Cleared

Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM, Model 29315

K052885510(k) TraditionalCleared Dec 23, 200571-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 USA, LLC · NHA Abutment, Implant, Dental, Endosseous

Cleared on Dec 23, 2005 as substantially equivalent to K944962 (Nobelpharma USA, Inc., 1995) after a 71-day review. Its family tree reaches back 1 generation to 1995. 20 later devices descend from it.

Decided
Dec 23, 2005
Review
71 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K944962 (1995). 20 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2025: 1 descendant cleared2015: 1 descendant cleared2016: 3 descendants cleared2010: 1 descendant cleared2018: 2 descendants cleared2019: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants cleared2022: 2 descendants cleared2020: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant clearedK944962 · Branemark System 17 Angulated Abutment · Nobelpharma USA, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 9 descendants5 generations forward: 1 descendant K944962 · Branemark System 17 Angulated Abutment · Nobelpharma USA, Inc. · 19950+5
  1. Root · 1 generation backK944962 Branemark System 17 Angulated AbutmentNobelpharma USA, Inc. · 1995
  2. This deviceK052885 Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17…Nobel Biocare USA, LLC · 2005
  3. Descendant · cites it directly · 19 of its ownK070182 Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007
  4. Descendant · 2 generations on · 10 of its ownK093562 Endosseous Dental ImplantSouthern Implants, Inc. · 2010
  5. Descendant · 2 generations on · 8 of its ownK141777 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
  6. Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
  7. Descendant · 2 generations on · 3 of its ownK152093 NobelZygoma 45°Nobel Biocare AB · 2016

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12015: 12016: 32017: 12018: 22019: 22020: 12021: 12022: 22023: 12024: 12025: 12026: 2
2007high 3 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 20 · See all
  • K070182Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007 · cites it directly19descendants
  • K093562Endosseous Dental ImplantSouthern Implants, Inc. · 2010 · 2 generations on10descendants
  • K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on8descendants
  • K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
  • K152093NobelZygoma 45°Nobel Biocare AB · 2016 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944962Branemark System 17 Angulated AbutmentNobelpharma USA, Inc.1995—
0 (this device)K052885Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment…Nobel Biocare USA, LLC2005—
+1K070182Zygoma Implant (Immediate Function)Nobel Biocare AB2007—
+2K093562Endosseous Dental ImplantSouthern Implants, Inc.2010—
+2K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2015—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.2016—
+2K152093NobelZygoma 45°Nobel Biocare AB2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201510
201630
201710
201820
201920
202010
202110
202220
202310
202410
202510
202620
FIG. 1 — Lineage of K052885, 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 30.7 · 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? (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
*K944962Branemark System 17 Angulated Abutment
Summary page 1
…872.3630) Trade or Proprietary or Model Name: Zygoma Angled Abutments Legally Marketed Devices: Branemark System 170 Angulated Abutment (K944962) Device Description: Nobel The Zyg…
Nobelpharma USA, Inc.1995—

Also cleared against K944962: 2 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K070182Zygoma Implant (Immediate Function)Nobel Biocare AB200719
K243834NobelZygoma TiUltra Implant systemNobel Biocare AB20250

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?

  • Its one ancestor has no recall.
  • Of its descendants, K070182 (Nobel Biocare AB, 2007) has gone furthest, with 19 descendants of its own.
  • 2 other devices also cite its predicate K944962.

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?

The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly connected to the implant and is intended for use as an aid in prosthetic rehabilitation.

Indications for use as stated in the FDA summary.

Also cleared against K944962

2 other devices cite the same predicate.

  • K123386Periotype X-PertClinical House Europe GmbH · 2013
  • K96173617 Angulated AbutmentNobelpharma USA, Inc. · 1996

More from Nobel Biocare USA, LLC

9 FDA decisions under this applicant name. See the company

  • K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC · 2014
  • K132746Nobelprocera Angulated Screw Channel Abutment Conical ConnectionNobel Biocare USA, LLC · 20145 recalls
  • K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC · 2011
  • K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC · 2008
  • K073142Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC · 20082 recalls

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/K052885 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052885: Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM, Model 29315.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052885

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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