Vericore Implant Abutments

FDA 510(k) K082299 · Whip-Mix Corp.

Substantially Equivalent

510(k) numberK082299

Submission

Device name
Vericore Implant Abutments
Applicant
Whip-Mix Corp.
Louisville, KY, US
Received
August 12, 2008
Decision date
November 20, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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More from Hiossen, Inc.

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K152443Vericore Gradient Temporary DiscEBG · Traditional 05/11/2016SE
K142670Vericore Zirconia BlanksEIH · Special 10/22/2014SE
K140877Vericore Zirconia BlanksEIH · Traditional 09/03/2014SE
K140146Comfortsoft Soft Denture Liner SystemEBI · Traditional 04/29/2014SE
K131760Whip Mix Preppies PlusEJR · Traditional 03/26/2014SE
K092857Vericore Abutment in Titanium for Implant SystemsNHA · Traditional 03/04/2010SE
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Questions and answers

When was Vericore Implant Abutments cleared by the FDA?

Vericore Implant Abutments (K082299) received a 510(k) decision of Substantially Equivalent on November 20, 2008, 100 days after the submission was received.

What is the product code of K082299?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.