510(k) Report

510(k) · Cleared

Cleared

Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236

K040573510(k) TraditionalCleared Apr 28, 200455-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 Apr 28, 2004 as substantially equivalent to K033724 (Nobel Biocare Uas, Inc., 2004) after a 55-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.

Decided
Apr 28, 2004
Review
55 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K962845 (1996). 2 later devices descend from it, 1 citing it directly.

  1. Root · 4 generations backK962845 Replace HA Coated ImplantsSteri-Oss, Inc. · 1996
  2. 3 generations backK021584 Replace Scalloped Margin Implant SystemNobel Biocare Uas, Inc. · 2002
  3. 2 generations backK030257 Nobel Perfect Implant SystemNobel Biocare Uas, Inc. · 2003
  4. 1 generation backK033724 Nobel Biocare Centric Post, Models 31234, 31235 and 31236Nobel Biocare Uas, Inc. · 2004
  5. This deviceK040573 Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236Nobel Biocare Uas, Inc. · 2004
  6. Descendant · cites it directly · 1 of its ownK050444 Nobelreplace Adapter, Model 32412Nobel Biocare Uas, Inc. · 2005
  7. Descendant · 2 generations on · 0 of its ownK063592 Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS…Nobel Biocare AB · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K050444Nobelreplace Adapter, Model 32412Nobel Biocare Uas, Inc. · 2005 · cites it directly1descendant
  • K063592Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP, 34553…Nobel Biocare AB · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K962845Replace HA Coated ImplantsSteri-Oss, Inc.1996—
−3K021584Replace Scalloped Margin Implant SystemNobel Biocare Uas, Inc.2002—
−2K030257Nobel Perfect Implant SystemNobel Biocare Uas, Inc.2003—
−1K033724Nobel Biocare Centric Post, Models 31234, 31235 and 31236Nobel Biocare Uas, Inc.2004—
0 (this device)K040573Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236Nobel Biocare Uas, Inc.2004—
+1K050444Nobelreplace Adapter, Model 32412Nobel Biocare Uas, Inc.2005—
+2K063592Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP…Nobel Biocare AB2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
FIG. 1 — Lineage of K040573, 1996–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K033724Nobel Biocare Centric Post, Models 31234, 31235 and 31236
Summary page 1
…Trade or Proprietary or Model Name: Nobel Biocare Permanent Centric Post Legally Marketed Device(s): Nobel Biocare Centric Post (K033724) Device Description: Nobel Biocare's Permanent Centric Post is a hollow, accessory component designed to enhance the performan…
Nobel Biocare Uas, Inc.2004—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K050444Nobelreplace Adapter, Model 32412Nobel Biocare Uas, Inc.20051

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 2 companies; a new generation was cleared every 1.0 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K050444 (Nobel Biocare Uas, Inc., 2005) has gone furthest, with 1 descendant of its own.

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 Permanent Centric Post is a support component indicated for use as both an alignment post to center an abutment, and as a seal to prohibit fluids from seeping into the implant interior.

The Nobel Biocare Permanent Centric Post is a component within the endosseous implant system, and is intended for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K040573: Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040573

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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