510(k) Report

510(k) · Cleared

Cleared

Vericore Abutment in Titanium for Implant Systems

K092857510(k) TraditionalCleared Mar 4, 2010169-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 Mar 4, 2010 as substantially equivalent to K090976 (Whip-Mix Corp., 2009) and 1 other predicate after a 169-day review. Its family tree reaches back 11 generations to 1995.

Decided
Mar 4, 2010
Review
169 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
2

Its longest line of descent runs back 11 generations to K944964 (1995). 76 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.

  1. Root · 11 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
  2. 7 generations between
  3. 3 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
  4. 2 generations backK082299 Vericore Implant AbutmentsWhip-Mix Corp. · 2008
  5. 1 generation backK090976 Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp. · 2009
  6. This deviceK092857 Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp. · 2010
Show all 11 generations
  1. Root · 11 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
  2. 10 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
  3. 9 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
  4. 8 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
  5. 7 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
  6. 6 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  7. 5 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  8. 4 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
  9. 3 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
  10. 2 generations backK082299 Vericore Implant AbutmentsWhip-Mix Corp. · 2008
  11. 1 generation backK090976 Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp. · 2009
  12. This deviceK092857 Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K944964Branemark System Miruscone Abutment SystemNobelpharma USA, Inc.1995—
−10K961728Miruscone Abutment SystemNobelpharma USA, Inc.1996—
−9K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc.1996—
−8K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc.1997—
−7K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc.19982
−6K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.20041
−5K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
−4K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis…Atlantis Components, Inc.2005—
−3K062277Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc.2006—
−2K082299Vericore Implant AbutmentsWhip-Mix Corp.2008—
−1K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.2009—
0 (this device)K092857Vericore 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
FIG. 1 — Lineage of K092857, 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 30.7 · 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? (2)

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
*K090976Vericore Abutment in Zirconia for Implant Systems
Summary page 1
….360 Product code: NRA 3. Legally Marketed Device to which Equivalence is claimed(Predicate Device) Vericore Abutments in Zirconia (K090976 and K082299) 4. Description of Device The Devices covered in this submission are abutments which are placed on the dental…
Whip-Mix Corp.2009—
*K082299Vericore Implant Abutments
Summary page 1
…Product code: NRA 3. Legally Marketed Device to which Equivalence is claimed(Predicate Device) Vericore Abutments in Zirconia (K090976 and K082299) 4. Description of Device The Devices covered in this submission are abutments which are placed on the dental implant…
Whip-Mix Corp.2008—

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 5 companies; a new generation was cleared every 10 months on median.
  • 8 of the 76 ancestors have a recall of any class.

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. 2010, 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 (223 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: Nobel Biocare, Southern Hexed, 3i, 3i Certain, Zimmer, Endopore, Nobel Replace, Southern Trilobe, Astra and Straumann.

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.

Angled abutments and narrow diameter implants 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 - Regular Hexed

3i Certain - Narrow, Regular, Wide

Southern Hexed - Narrow, Regular, Wide

Endopore - Narrow, Regular and 5mm

Nobel Replace- Narrow, Regular, Wide and 6mm

Southern Trilob e - Narrow, Regular and Wide

Astra - Narrow and Regular

Straumarn - Narrow, Regular and Wide

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K092857: Vericore Abutment in Titanium for Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092857

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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