510(k) Report

510(k) · Cleared

Cleared

Vericore Abutment in Zirconia for Implant Systems

K090976510(k) TraditionalCleared Jun 25, 200980-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 Jun 25, 2009 as substantially equivalent to K082299 (Whip-Mix Corp., 2008) and 4 other predicates after an 80-day review. Its family tree reaches back 10 generations to 1995. 1 later device descends from it.

Decided
Jun 25, 2009
Review
80 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K944964 (1995). 75 ancestors in all, the oldest K871863 (1987). 1 later device descends from it, 1 citing it directly.

  1. Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
  2. 6 generations between
  3. 3 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
  4. 2 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
  5. 1 generation backK082299 Vericore Implant AbutmentsWhip-Mix Corp. · 2008
  6. This deviceK090976 Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp. · 2009
  7. Descendant · cites it directly · 0 of its ownK092857 Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp. · 2010
Show all 10 generations
  1. Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
  2. 9 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
  3. 8 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
  4. 7 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
  5. 6 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
  6. 5 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  7. 4 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  8. 3 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
  9. 2 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
  10. 1 generation backK082299 Vericore Implant AbutmentsWhip-Mix Corp. · 2008
  11. This deviceK090976 Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • 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
−10K944964Branemark System Miruscone Abutment SystemNobelpharma USA, Inc.1995—
−9K961728Miruscone Abutment SystemNobelpharma USA, Inc.1996—
−8K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc.1996—
−7K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc.1997—
−6K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc.19982
−5K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.20041
−4K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
−3K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis…Atlantis Components, Inc.2005—
−2K062277Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc.2006—
−1K082299Vericore Implant AbutmentsWhip-Mix Corp.2008—
0 (this device)K090976Vericore 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
198810
198910
199010
199110
199390
1994100
199550
199650
199730
199850
199960
200030
200130
200230
200330
200610
200740

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K090976, 1995–2010Source: 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 30.6 · 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? (5)

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
*K082299Vericore Implant Abutments
Summary page 1
…Product code: NHA 3. Legally Marketed Device to which Equivalence is claimed(Predicate Device) Vericore Zirconia Abutments for Replace K082299 Atlantis Zirconia Abutments K071946, K052070, K062277 4. Description of Device The Devices covered i…
Whip-Mix Corp.2008—
*K071946Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants
Summary page 1
…Legally Marketed Device to which Equivalence is claimed(Predicate Device) Vericore Zirconia Abutments for Replace K082299 Atlantis Zirconia Abutments K071946, K052070, K062277 4. Description of Device The Devices covered in this submission are abutments which are plac…
Atlantis Components, Inc.2007—
*K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +…
Summary page 1
…arketed Device to which Equivalence is claimed(Predicate Device) Vericore Zirconia Abutments for Replace K082299 Atlantis Zirconia Abutments K071946, K052070, K062277 4. Description of Device The Devices covered in this submission are abutments which are placed on the…
Atlantis Components, Inc.2005—
*K062277Atlantis Abutment in Zirconia for Nobel Biocare Replace
Summary page 1
…evice to which Equivalence is claimed(Predicate Device) Vericore Zirconia Abutments for Replace K082299 Atlantis Zirconia Abutments K071946, K052070, K062277 4. Description of Device The Devices covered in this submission are abutments which are placed on the…
Atlantis Components, Inc.2006—
*K063734Atlantis Abutment in Zirconia for 3I Certain Interface
Summary page 2
…to the endosseous implant. 6. Basis for Substantial Equivalence Vericore abutments are substantially equivalent to Atlantis Zirconia Abutments (K052070 and K063734). Both devices are Zirconia abutments designed to fit the Nobel Biocare, 3i, Zimmer, and Endopore implants.…
Atlantis Components, Inc.2007—

Also cleared against K082299: 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
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 14 years and passes through 5 companies; a new generation was cleared every 12 months on median.
  • 8 of the 75 ancestors have a recall of any class.
  • Of its descendants, K092857 (Whip-Mix Corp., 2010) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K082299.

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. 2009, 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 (210 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.

This device is compatible with the following manufacturers' implant systems:

Branemark, Southern Hexed, 3i, 3i Certain, Zimmer and Endopore.

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. 15. 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.

Zimmer - Narrow, Regular, Wide

Nobel Biocare - Narrow, Regular, Wide

3i -Micro Mini, Regular Hexed, 5mm

3i Certain- Narrow, Regular, Wide

Southern Hexed - Narrow, Regular, Wide

Endopore - Narrow, Regular and 5mm

Astra - Narrow and Regular

Straumann - Narrow, Regular, Wide

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K090976: Vericore Abutment in Zirconia for Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090976

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