The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. In 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 implan 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 foor 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 (3.5mm), Regular (4.3mm) and Wide (5.0mm)

Device Description

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws and adaptors are made from Titanium grade Ti-6A1-4V for the screws and Grade 4 for the adaptors. 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. The abutments are compatible with the following implant systems:

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

AI/ML Overview

The provided text is a 510(k) summary for the Vericore™ Abutment, a dental implant abutment. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study demonstrating device performance.

Therefore, I cannot provide the requested table and study details.

The document primarily focuses on:

Device Description: What the Vericore Abutment is made of and how it functions.
Intended Use: The clinical purpose of the abutment.
Predicate Device: The legally marketed device (Atlantis Zirconia Abutments) to which equivalence is claimed.
Regulatory Information: FDA’s determination of substantial equivalence and general controls applicable to the device.

There is no mention of any performance studies, clinical trials, or bench tests with specific acceptance criteria or results. The FDA's 510(k) clearance process for devices like this often relies on demonstrating substantial equivalence to a predicate device, sometimes through physical and mechanical testing, but the details of such testing (if performed and submitted) are not present in this summary.

Summary

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K082299
VII. Section 10 – 510(K) Summary

This summary of 510(K) substantial equivalcnce information is bcing submitted in accordance with requirements of 21 CFR Part 807.92

1. Applicant's Name and Address

NOV 2 0 2008

Whip Mix Corporation, Lab Services Division 361 Farmington Ave. Louisville, Kentucky 40217 Telephone Number: 502-634-1451 Fax Number: 502-634-4512 Contact Person: Frederick T. Kapp Quality Manager

2. Name of Device

Trade Name: Common Name: Classification Name: Vericore™ Abutment Endosseous dental implant abutment Endosseous dental implant abutment 21 CFR 872.360 NHA

Product code:

Legally Marketed Device to which Equivalence is claimed(Predicate 3. Device) Atlantis Zirconia Abutments for Replace K062277

4. Description of Device

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

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

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K082299

న్. Intended use of the Device

The intended uses of the devices covered by this submission are abutments which are placed on the dental implant to provide support for a prosthetic reconstruction. The Vericore abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous pationt. It is intended for use to support a single and multiple tooth prosthesis, in the mandible or maxilla. The abutment screw is intended to secure the abutment to the endosseous implant.

Basis for Substantial Equivalence 6.

Vericore abutments are substantially equivalent to Atlantis Zirconia Abutments for Nobel Replace (K06227). Both devices are Zirconia abutments designed to fit the Nobel Replace implants.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David J. Steinbock Vice President Corporate Services Whip Mix Corporation Lab Services Division 361 Farmington Avenue Louisville, Kentucky 40217

NOV 2 0 2008

Re: K082299

Trade/Device Name: Vericore m Abutment in Zirconia for Implant Systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 12, 2008 Received: November 12, 2008

Dear Mr. Steinbock:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Steinbock

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Qve

Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K082299

Indications for Use

510(k) Number:

Device Name: Vericore™ Abutiment in Zirconia for Implant Systems, See list below.l

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. In is intended for use to support single and multiple tooth prosthesis, in the mand ble or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

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.

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

AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Susa Runse

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082099

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)