510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Quickbridge TM Cylinder and Cap

K071551510(k) TraditionalCleared Aug 30, 200785-day reviewClass II21 CFR 872.3630Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet 3i, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Aug 30, 2007 as substantially equivalent to K061177 (Implant Innovations, Inc., 2006) after an 85-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it. It has been recalled once.

Decided
Aug 30, 2007
Review
85 days
Class
Class II
Product code
NHA
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K871954 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2013: 1 descendant clearedK871954 · Abutment Head Post · Implant Innovations International, Inc. · 1987×2: 2 generations cleared close together, K053170 (2006), K061177 (2006) 1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 1 descendant K061177 · Provide Temporary Cylinder · Implant Innovations, Inc. · 2006K053170 · Preformance Posts · Implant Innovations, Inc. · 2006 · recalledK871954 · Abutment Head Post · Implant Innovations International, Inc. · 19870
  1. Root · 3 generations backK871954 Abutment Head PostImplant Innovations International, Inc. · 1987
  2. 2 generations backK053170 Preformance PostsImplant Innovations, Inc. · 2006 · Recalled
  3. 1 generation backK061177 Provide Temporary CylinderImplant Innovations, Inc. · 2006
  4. This deviceK071551 Quickbridge TM Cylinder and CapBiomet 3i, Inc. · 2007
  5. Descendant · cites it directly · 0 of its ownK130310 Certain Bellatek Provisional AbutmentsBiomet 3i · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K130310Certain Bellatek Provisional AbutmentsBiomet 3i · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K871954Abutment Head PostImplant Innovations International, Inc.1987—
−2K053170Preformance PostsImplant Innovations, Inc.20063
−1K061177Provide Temporary CylinderImplant Innovations, Inc.2006—
0 (this device)K071551Quickbridge TM Cylinder and CapBiomet 3i, Inc.2007—
+1K130310Certain Bellatek Provisional AbutmentsBiomet 3i2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K071551, 1987–2013Source: 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? (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
*K061177Provide Temporary Cylinder
Summary page 1
…ification Dental Devices Panel 21 CFR § 872.3630 Legally Marketed Certain Provide Temporary Cylinder, K061177, 5/16/06 Predicate Devices Device Description The QuickBridge provisional components consist of a non-…
Implant Innovations, Inc.2006—

Also cleared against K061177: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K130310Certain Bellatek Provisional AbutmentsBiomet 3i20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2015Class IIZ-2442-2016PackagingPouches may not have been sealed during packing.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K130310 (Biomet 3i, 2013) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K061177.

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 QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K071551: Quickbridge TM Cylinder and Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071551

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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