510(k) Report

510(k) · Cleared

Cleared

Vericore Implant Abutments

K082299510(k) TraditionalCleared Nov 20, 2008100-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

Whip-Mix Corp. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Nov 20, 2008 as substantially equivalent to K062277 (Atlantis Components, Inc., 2006) after a 100-day review. Its family tree reaches back 9 generations to 1995. 2 later devices descend from it.

Decided
Nov 20, 2008
Review
100 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K944964 (1995). 51 ancestors in all, the oldest K871863 (1987). 2 later devices descend from it, 2 citing it directly.

  1. Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
  2. 5 generations between
  3. 3 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  4. 2 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
  5. 1 generation backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
  6. This deviceK082299 Vericore Implant AbutmentsWhip-Mix Corp. · 2008
  7. Descendant · cites it directly · 1 of its ownK090976 Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp. · 2009
  8. Descendant · cites it directly · 0 of its ownK092857 Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp. · 2010
Show all 9 generations
  1. Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
  2. 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
  3. 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
  4. 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
  5. 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
  6. 4 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  7. 3 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  8. 2 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
  9. 1 generation backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
  10. This deviceK082299 Vericore Implant AbutmentsWhip-Mix Corp. · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp. · 2009 · cites it directly1descendant
  • K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K944964Branemark System Miruscone Abutment SystemNobelpharma USA, Inc.1995—
−8K961728Miruscone Abutment SystemNobelpharma USA, Inc.1996—
−7K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc.1996—
−6K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc.1997—
−5K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc.19982
−4K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.20041
−3K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
−2K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis…Atlantis Components, Inc.2005—
−1K062277Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc.2006—
0 (this device)K082299Vericore Implant AbutmentsWhip-Mix Corp.2008—
+1K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.2009—
+1K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199010
199110
199390
199490
199540
199650
199720
199820
199930
200010
200110
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
FIG. 1 — Lineage of K082299, 1995–2010Source: 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
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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
*K062277Atlantis Abutment in Zirconia for Nobel Biocare Replace
Summary page 1
…Product code: NHA 3. Legally Marketed Device to which Equivalence is claimed(Predicate Device) Atlantis Zirconia Abutments for Replace K062277 4. Description of Device The Devices covered in this submission are abutments which are placed on the…
Atlantis Components, Inc.2006—

Also cleared against K062277: 4 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.20091
K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100

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 13 years and passes through 5 companies; a new generation was cleared every 12 months on median.
  • 7 of the 51 ancestors have a recall of any class.
  • Of its descendants, K090976 (Whip-Mix Corp., 2009) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K062277.

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. 2008, 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 Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The abutment is placed over the implant and is mounted on…

Read the full statement (228 words)

The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implant that can not be milled into the abutment.

This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Trilock.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Also highly angled abutments (i.e. 28 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm

Southern Trilock - Narrow (3.5rrm), Regular (4.3nmm) and Wide (5.0mm)

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K082299: Vericore Implant Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082299

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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