510(k) Report

510(k) · Cleared

Cleared

Primaconnex RD and WD Esthetic Contour ZI Abutments

K072572510(k) SpecialCleared Oct 5, 200723-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

Lifecore Biomedical, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Oct 5, 2007 as substantially equivalent to K063602 (Zoll Circulation, 2006) after a 23-day review. Its family tree reaches back 5 generations to 1985. 1 later device descends from it.

Decided
Oct 5, 2007
Review
23 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K851139 (1985). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

  1. Root · 5 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
  2. 4 generations backK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
  3. 3 generations backK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
  4. 2 generations backK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
  5. 1 generation backK063602 Autopulse Resuscitation System MODEL100Zoll Circulation · 2006 · Recalled
  6. This deviceK072572 Primaconnex RD and WD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc. · 2007
  7. Descendant · cites it directly · 0 of its ownK073032 Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K851139Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc.1985—
−4K022345Autopulse Resuscitation SystemRevivant Corp.20022
−3K032852Modification to: Autopulse Resuscitation System Model 100Revivant Corp.20032
−2K040453Autopulse Resuscitation System, Model 100Revivant Corp.20042
−1K063602Autopulse Resuscitation System MODEL100Zoll Circulation20061
0 (this device)K072572Primaconnex RD and WD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.2007—
+1K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K072572, 1985–2007Source: 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
*K063602Autopulse Resuscitation System MODEL100
Summary page 1
…djunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse. Predicate Devices K063602 AutoPulse® Resuscitation System Model 100 Device Description AutoPulse Resuscitation System Model 100 ("Device") i…
Zoll Circulation20061

Also cleared against K063602: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.20070

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 22 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • 5 of the 6 ancestors have a recall of any class.
  • Of its descendants, K073032 (Lifecore Biomedical, Inc., 2007) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K063602.

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. 2007, 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 AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072572: Primaconnex RD and WD Esthetic Contour ZI Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072572

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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