(169 days)
Not Found
No
The 510(k) summary describes a physical dental abutment and its compatibility with various implant systems. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies described are standard mechanical and dimensional tests for physical devices.
No.
This device is an accessory to an endosseous implant for supporting a prosthetic device, which is restorative and not therapeutic in nature. The device description explicitly states it provides support for a prosthetic restoration, not treatment for a disease or condition.
No
The Vericore Abutment is an accessory to an endosseous implant designed to support a prosthetic device. Its description and intended use focus on mechanical support and compatibility with implant systems, not on diagnosing medical conditions.
No
The device description explicitly states the device is an "abutment" made from "Titanium grade Ti-6Al-4V" and includes "abutment screws" also made from Titanium. This indicates a physical, hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Vericore Abutment is an accessory to a dental implant used to support a prosthetic device in a patient. This is a direct medical device used in vivo (within the body).
- Device Description: The description details the physical components and materials of the abutment and screw, which are implanted into the patient's jawbone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant component used in vivo.
N/A
Intended Use / Indications for Use
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 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
Product codes
NHA
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 Titanium grade Ti-6Al-4V. The abutment screws and are made from Titanium grade Ti-6A1-4V. The abutment is made to be placed over the implant and is mounted on to the implant with an abutment screw. The abutments are compatible with the following implant systems: 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 Trilock - Narrow, Regular and Wide Astra - Narrow and Regular Straumann - Narrow, Regular and Wide
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla, anterior region of the mouth, posterior region of the mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Fatigue Testing: Fatigue testing was conducted according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants with the worst case scenario for each connection platform style for the Vericore Custom Abutment in Titanium and an angled abutment. The resulting information demonstrated a substantial equivalence of both the fatigue failure load and fatigue failure mode to predicate devices.
Dimensional Analysis: Dimensional analysis was conducted on the implant and abutment interfaces in order to determine the dimensions for the Vericore Custom Abutments in Titanium.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
K09285-7
VII. Section 10 - 510(K) Summary
This summary of 510(K) substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92
1. Applicant's Name and Address
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: Vericore Custom Abutment in Titanium - for Implant Systems: NobelBiocare, Southern Hexed, Zimmer, 3i, 3i Certain, Straumann, Nobel Replace, Southern Trilobe, Astra, and Endospore. Common Name: Endosseous dental implant abutment Classification Name: Endosseous dental implant abutment 21 CFR 872.360 Product code: NHA
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.
Vericore Abutments are made from Titanium grade Ti-6Al-4V. The abutment screws and are made from Titanium grade Ti-6A1-4V. The abutment is made to be placed over the implant and is mounted on to the implant with an abutment screw. The abutments are compatible with the following implant systems: 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 Trilock - Narrow, Regular and Wide Astra - Narrow and Regular Straumann - Narrow, Regular and Wide
1
5. Indications for Use
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.
List a
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 Trilock - Narrow, Regular and Wide Astra -- Narrow and Regular Straumann - Narrow, Regular and Wide
6. Non-clinical Testing Data
Fatigue Testing
Fatigue testing was conducted according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants with the worst case scenario for each connection platform style for the Vericore Custom Abutment in Titanium and an angled abutment. The resulting information demonstrated a substantial equivalence of both the fatigue failure load and fatigue failure mode to predicate devices.
Dimensional Analysis
Dimensional analysis was conducted on the implant and abutment interfaces in order to determine the dimensions for the Vericore Custom Abutments in Titanium.
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7. Basis for Substantial Equivalence
Vericore abutments are substantially equivalent to Vericore Zirconia Abutments for (K090976). Both devices are abutments made for the implant systems named above. The interface designs are the same, the same dimensional analysis was done and the fatigue testing showed substantial equivalence. The indications for use for the 2 Vericore systems is the same. The submitted abutments of Titanium are substantially equivalent to the abutments made in Zirconia.
Date the Summary Was Prepared: March 2, 2010
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is composed of three curved lines that resemble a human figure in motion or a stylized representation of the flow of services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 4 2010
Mr. Frederick T. Kapp Quality Manager Whip Mix Corporation Lab Services Division 361 Farmington Avenue Louisville, Kentucky 40217
Re: K092857
Trade/Device Name: Vericore Custom Abutment in Titanium - for Implant Systems: NobelBiocare, Southern Hexed, Zimmer, 3i, 3i Certain, Straumann, Nobel Replace, Southern Trilobe, Astra, and Endospore (see attached list a)
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 18, 2010 Received: February 19, 2010
Dear Mr. Kapp:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Kapp
Please be advised that FDA's issuance of a substantial equivalence determination does 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
Device Name: Vericore Custom Abutment in Titanium - for Implant Systems: NobelBiocare, Southern Hexed, Zimmer, 3i, 3i Certain, Straumann, Nobel Replace, Southern Trilobe, Astra, and Endospore (see attached list a)
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 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
List a
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 Trilock - Narrow, Regular and Wide Astra - Narrow and Regular Straumann - Narrow, Regular and Wide
Prescription Use AND/OR Over-The-Counter Use × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF As Betz Sons NEEDED)
BsBetz, DDS for Dr. K.P. Mulez
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092857