(131 days)
The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration
The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System is designed for use with Zimmer 3.1mmD Dental Implants to support single or multi tooth restorations. The new abutment will be offered in a 2.9mm implant platform.
The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System is a patient specific dental implant abutment. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist.
Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.
The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.
The abutment is composed of Titanium alloy (Ti6Al4V ELI), and secured to the implant with a separate Titanium alloy screw for retention.
This 510(k) premarket notification describes the Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System, a custom dental implant abutment made from Titanium alloy (Ti6Al4V ELI). The submission aims to demonstrate substantial equivalence to a predicate device, the Zimmer Patient-Specific Abutment, Internal Hex, Titanium (K071439).
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it refers to compliance with an FDA guidance document and states that the new device demonstrated improvements over the predicate in certain non-clinical tests.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength: Withstand anticipated forces (Fatigue and Compression) | "Non-clinical testing consisted of performance of fatigue and compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the new device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device(s)." (This indicates the device met or exceeded the requirements outlined in the guidance and performed better than the predicate in these tests.) |
| Sterilization Efficacy: Achieve minimum sterility assurance level (SAL). | "The sterilization procedures listed in the Instruction For Use were validated to provide a minimum sterility assurance level of 10-9." (This is a clear statement of meeting the SAL of 10^-9.) |
| MRI Compatibility: Pose no additional restrictions on MRI compared to patient. | "Additionally, Zimmer Dental implant systems were evaluated for interactions with magnetic fields during Magnetic Resonance Imaging (MRI) in accordance with the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. This was done to determine that the presence of the abutment poses no additional restrictions on MRI beyond those that would otherwise occur for the patient." (This confirms the evaluation was done, and the outcome indicates no additional restrictions, implying compatibility within the guidance for passive implants.) |
| Material Equivalence: (Implicit from comparison table) | The device is made of "Titanium 6Al-4V ELI," which is the same as the predicate device. |
| Manufacturing Process & General Design Features Equivalence: (Implicit from comparison table) | Stated that "The new abutment device is substantially equivalent to the predicate relative to material, manufacturing process and general design features." While specific metrics aren't provided here, the comparison table details design features (Implant Interface, Emergence, Margin, Platform Diameter, Cuff Width/Diameter, Minimum Height, Cone Angle), indicating that the new device's design falls within acceptable ranges or is comparable to the predicate, with modifications to platform diameter and cuff width/diameter being highlighted as specific differences allowed by the "patient-specific" nature. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for the fatigue, compression, or sterilization validation tests.
- Data Provenance: The tests were "non-clinical" and performed by Zimmer Dental, Inc. The country of origin for the data is not explicitly stated, but given the company's address in Carlsbad, CA, it's presumed to be the USA. The data is from a prospective testing regimen designed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the study was non-clinical (mechanical, sterilization, and MRI compatibility testing). There was no "ground truth" in the context of expert diagnosis or interpretation of data in the way it's typically understood for AI/medical imaging devices. The "ground truth" for these tests would be the measured physical properties and performance against established engineering and regulatory thresholds.
4. Adjudication Method for the Test Set:
This information is not applicable as the study was non-clinical. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness." This device is an implantable medical device, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. The device is a physical dental implant abutment, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this non-clinical study relied on:
- Engineering Standards and Regulatory Guidance: Performance was evaluated against the "FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments" for mechanical properties and the "FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" for MRI compatibility.
- Analytical Measurement Outcomes: The results of the fatigue, compression, sterilization, and MRI compatibility tests serve as the "ground truth" for whether the device meets the specified performance criteria derived from these standards. For example, a measured force to failure during compression testing provides a numerical ground truth for mechanical strength.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require training sets.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
{0}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2015
Zimmer Dental, Inc. Ms. Christina Boydston Regulatory Affairs Manager 1900 Aston Avenue Carlsbad, California 92008
Re: K142572
Trade/Device Name: Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: December 19, 2014 Received: December 22, 2014
Dear Ms. Boydston:
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.
{1}------------------------------------------------
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
| 510(k) Number (if known): | K142572 |
|---|---|
| --------------------------- | --------- |
Device Name: Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
Indications For Use:
The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
Zimmer Dental 1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
1. Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008 | |
| Phone: | 760-929-4300 |
| Contact: | Christina Boydston |
| Date Prepared: | September 10, 2014 |
-
- Device Name: Trade Name:
Regulation Number: Classification Code: Device Classification Name: Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System 872.3630 NHA Abutment, Implant, Dental, Endosseous
- Device Name: Trade Name:
-
- Predicate Device(s):
Predicate Device No. 1 Trade Name:
- Predicate Device(s):
510(k) Number: Regulation Number: Classification Code: Device Classification Name: Zimmer Patient-Specific Abutment, Internal Hex, Titanium K071439 872.3630 NHA Abutment, Implant, Dental, Endosseous
4. Device Description:
The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System is designed for use with Zimmer 3.1mmD Dental Implants to support single or multi tooth restorations. The new abutment will be offered in a 2.9mm implant platform.
The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System is a patient specific dental implant abutment. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist.
{4}------------------------------------------------
Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.
The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.
The abutment is composed of Titanium alloy (Ti6Al4V ELI), and secured to the implant with a separate Titanium alloy screw for retention.
న్. Indications for Use:
The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System. Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration
6. Device Comparison:
The new abutment device is substantially equivalent to the predicate relative to material, manufacturing process and general design features. It is fabricated from Titanium alloy. The new abutment will be affixed to the implant by a retaining screw, the same manner as the predicate.
| Feature | New DeviceZimmer Zfx Abutment for Zimmer2.9mmD Platform | Predicate #1Zimmer Patient-SpecificAbutment, Internal Hex, Titanium |
|---|---|---|
| Material | Titanium 6Al-4V ELI | Titanium 6Al-4V ELI |
| ImplantInterface | Internal Hex, Friction fitConical Connection, Friction fit | Internal Hex, Friction-Fit |
| Emergence | Contoured/curved depending onanatomy | Contoured/curved depending onanatomy |
| Margin | Pre-machined | Pre-machined |
| PlatformDiameter | 2.9mm | 3.5, 4.5, 5.7mm |
| Cuff Width/Diameter | 2.9mm-9.0mm | 3.5mm-8.0mm |
| MinimumHeight | 3.0 MIN Cone3.0-12.0 Overall | 3.0-11.5 Cone3.5-12.0 Overall |
| Cone Angle | 0-30° | 0-30° |
6. Technological Characteristics
{5}------------------------------------------------
| RetainingScrew | Cat No. CUAS | Cat No. MHLAS |
|---|---|---|
| -------------------- | -------------- | --------------- |
8. Non-Clinical Testing:
Non-clinical test data was used to support the decision of substantial Non-clinical testing consisted of performance of fatigue and equivalence. compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the new device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device(s).
In addition, the Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System will be sold non-sterile and will be sterilized by the end user. The sterilization procedures listed in the Instruction For Use were validated to provide a minimum sterility assurance level of 10-9.
Additionally, Zimmer Dental implant systems were evaluated for interactions with magnetic fields during Magnetic Resonance Imaging (MRI) in accordance with the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. This was done to determine that the presence of the abutment poses no additional restrictions on MRI beyond those that would otherwise occur for the patient.
Clinical Testing 9.
No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.
10. Conclusion
Based on our analysis, the device is substantially equivalent to the predicate.
§ 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.)