(131 days)
Not Found
No
The description focuses on traditional manufacturing and design processes for patient-specific abutments, without mentioning any AI or ML involvement in the design or fabrication process.
Yes.
The device is an abutment for a dental implant system, directly supporting a prosthesis and restoring the function of missing teeth, which aligns with the definition of a therapeutic device.
No
The device description clearly states its purpose as a dental implant abutment used to support tooth restorations, not to diagnose medical conditions.
No
The device description explicitly states the abutment is composed of Titanium alloy and is secured with a Titanium alloy screw, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is used as a terminal or intermediate abutment for a cemented prosthesis in the mouth. This is a structural component for dental restoration.
- Device Description: The description details a physical component designed to connect a dental implant to a prosthesis. It's a mechanical device.
- 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.
- Anatomical Site: The device is used in the dental anatomy, which is a physical location on the body, not a biological specimen.
- Performance Studies: The performance studies focus on mechanical properties (fatigue, compression) and sterilization, which are relevant to a physical implant component, not an IVD.
In summary, the Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System is a dental implant component, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes
NHA
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Non-clinical test data was used to support the decision of substantial equivalence. 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).
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.
No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Device
Zimmer Zfx Abutment for Zimmer
2.9mmD Platform | Predicate #1
Zimmer Patient-Specific
Abutment, Internal Hex, Titanium |
|-------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------|
| Material | Titanium 6Al-4V ELI | Titanium 6Al-4V ELI |
| Implant
Interface | Internal Hex, Friction fit
Conical Connection, Friction fit | Internal Hex, Friction-Fit |
| Emergence | Contoured/curved depending on
anatomy | Contoured/curved depending on
anatomy |
| Margin | Pre-machined | Pre-machined |
| Platform
Diameter | 2.9mm | 3.5, 4.5, 5.7mm |
| Cuff Width/
Diameter | 2.9mm-9.0mm | 3.5mm-8.0mm |
| Minimum
Height | 3.0 MIN Cone
3.0-12.0 Overall | 3.0-11.5 Cone
3.5-12.0 Overall |
| Cone Angle | 0-30° | 0-30° |
6. Technological Characteristics
5
| Retaining
| Screw | 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.