(115 days)
Not Found
No
The summary describes a patient-specific dental implant abutment manufactured based on customer needs and established limits, without mentioning any AI or ML algorithms for design or manufacturing.
No.
The Zimmer Zfx Titanium Abutment is a component used in dental implant systems to support restorations, and while it aids in the restoration of dental function, it is not described as directly preventing, treating, or diagnosing a disease or condition in the way a therapeutic device typically would. Its primary function is mechanical support.
No
The device is a dental implant abutment designed to mechanically support dental prostheses, not to provide diagnostic information. Its function is restorative, not diagnostic.
No
The device is a physical dental abutment made of titanium alloy, not software. The description details its material composition, design for supporting dental restorations, and mechanical testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that the Zimmer Zfx Titanium Abutment is a dental implant abutment designed to be used in the mouth to support dental restorations. It is a physical component implanted into the patient.
- Intended Use: The intended use is as a terminal or intermediate abutment for cement-retained prostheses, which is a structural component for dental work.
- Lack of IVD Characteristics: The text does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes related to disease detection.
Therefore, the Zimmer Zfx Titanium Abutment for NobelActive Implant System is a medical device, specifically a dental implant component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a Narrow Platform (NP) Ø 3.5mm or Regular Platform (RP) Ø 3.9mm
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Zimmer Zfx Titanium Abutment for the NobelActive Implant system is designed for use with NobelActive and NobelReplace Conical Connection endosseous dental implants to support single or multi tooth restorations. The abutment/implant interface is an internal conical connection with a hexagonal interlock.
The Zimmer Zfx Titanium Abutment for NobelActive Implant System is a patient specific dental implant abutment with a competitor compatible interface. 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), and is secured to the implant with a separate Titanium alloy screw for retention.
The new abutments will all be available with a choice of 3.5mm and 3.9mm implant platform diameters.
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
Not Found
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)
Non-clinical test data was used to support the decision of substantial equivalence. This consisted of reverse engineering, compatibility analysis and mechanical fatigue testing. The NobelActive interface was reverse engineered based on actual measurements taken from NobelActive implants, abutments and retaining screws in order to assure that the Zimmer Zfx Titanium Abutmentis compatible with NobelActive and NobelReplace Conical Connection Implant Systems. Dimensional specifications were developed for the Zimmer fabricated components based on the reverse engineering results. A tolerance analysis as well as a rotational analysis was conducted to illustrate the nature of fit between the Zimmer fabricated parts and the OEM implant. To verify the compatibility of the Zimmer device to the OEM device, fatigue testing was completed using Zimmer fabricated abutments assembled to OEM implants in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The results were compared to fatigue testing data of the predicate #3 device. Based on the reverse engineering process, as well as verification of the final connection dimensions and tolerances, the Zimmer Zfx Titanium Abutment for NobelActive Implant System can be deemed compatible with the NobelActive and NobelReplace Conical Connection implant interface. The Zimmer Zfx Titanium Abutment for the NobelActive 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 10-6. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
APR 2 5 2014
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))
l . Submitter's Information:
- Name: Address: Phone:
Zimmer Dental Inc. 1900 Aston Ave. Carlsbad. CA 92008 760-929-4300
Date Prepared: April 23, 2014
-
- Device Name: Trade Name:
Contact:
- Device Name: Trade Name:
Regulation Number: Classification Code: Device Classification Name: Zimmer Zfx Titanium Abutmentfor NobelActive Implant System 872.3630 NHA Endosseous Dental Implant Abutment
3. Predicate Device(s):
Predicate Device No. 1 Trade Name:
510(k) Number: Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 2 Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 3 Trade Name : 510(k) Number: Regulation Number : Classification Code : Device Classification Name : Zimmer Zfx Abutment for NobelReplace Implant System K120873 872.3630 NHA Endosseous Dental Implant Abutment
NobelProcera Ti Abutment K091756 872.3630 NHA Endosseous Dental Implant Abutment
Nobel Active Internal Connection Implant K071370 872.3640 DZE Implant, Endosseous, Root-Form
1
4. Device Description:
The Zimmer Zfx Titanium Abutment for the NobelActive Implant system is designed for use with NobelActive and NobelReplace Conical Connection endosseous dental implants to support single or multi tooth restorations. The abutment/implant interface is an internal conical connection with a hexagonal interlock.
The Zimmer Zfx Titanium Abutment for NobelActive Implant System is a patient specific dental implant abutment with a competitor compatible interface. 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), and is secured to the implant with a separate Titanium alloy screw for retention.
The new abutments will all be available with a choice of 3.5mm and 3.9mm implant platform diameters.
5. Indications for Use:
The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a Narrow Platform (NP) Ø 3.5mm or a Regular Platform (RP) Ø 3.9mm.
Device Comparison: 6.
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 and utilizes an internal conical connection with hexagonal
2
interlocking implant/abutment interface, which is identical in size and shape (for a given platform diameter) to the predicate device. The new abutment device will be affixed to the implant by a retaining screw, the same manner as the predicate.
6. Technological Characteristics
| Feature | New Device
Zimmer Zfx Titanium
Abutment for NobelActive
Implant System | Predicate #1
Zimmer Zfx Abutment
for NobelReplace
Implant System | Predicate #2
NobelProcera (for
NobelActive implants) | Predicate #3
Nobel Esthetic Abutment
Conical Connection, NP |
|----------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------|
| Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V |
| Implant
Interface | Internal Conical,
Internal Hex | Internal Tri-lobe | Internal Conical, Internal
Hex | Internal Conical, Internal
Hex |
| Emergence | Contoured, curved | Contoured, curved | Contoured, curved | Contoured, curved |
| Margin | Pre-machined | Pre-machined | Pre-machined | Pre-machined |
| Platform
Diameter | 3.5mm, 3.9mm | 3.5mm, 4.3mm,
5.0mm, 6.0mm | 3.5mm, 3.9mm | 3.5mm, 3.9mm |
| Cuff Width | 3.0mm-9mm (NP)
3.4mm-9mm (RP) | 3.5mm-12.0mm | 16mm MAX | 4.8mm |
| Minimum
Height | 3.0mm MIN Cone
3.0mm-12.0mm Overall | 3.0- 11.5mm Cone
3.5-12.0mm Overall | 15mm MAX Overall | 6.5mm Cone
8.0mm, 9.5mm and
11.5mm Overall |
| Retaining
Screw | New device | ZFX09000642 | Cat No. 36917 and 36918 | Cat. No. 36917 and 36918 |
| Cone Angle | 0-25° | 0-20° | 0-25° | 25° |
8. Non-Clinical Testing:
Non-clinical test data was used to support the decision of substantial equivalence. This consisted of reverse engineering, compatibility analysis and mechanical fatigue testing. The NobelActive interface was reverse engineered based on actual measurements taken from NobelActive implants, abutments and retaining screws in order to assure that the Zimmer Zfx Titanium Abutmentis compatible with NobelActive and NobelReplace Conical Connection Implant Systems. Dimensional specifications were developed for the Zimmer fabricated components based on the reverse engineering results. A tolerance analysis as well as a rotational analysis was conducted to illustrate the nature of fit between the Zimmer fabricated parts and the OEM implant. To verify the compatibility of the Zimmer device to the OEM device, fatigue testing was completed using Zimmer fabricated abutments assembled to OEM implants in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The results were
3
compared to fatigue testing data of the predicate #3 device. Based on the reverse engineering process, as well as verification of the final connection dimensions and tolerances, the Zimmer Zfx Titanium Abutment for NobelActive Implant System can be deemed compatible with the NobelActive and NobelReplace Conical Connection implant interface.
The Zimmer Zfx Titanium Abutment for the NobelActive 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 10-6.
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.
9. Clinical Testing
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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble human figures or waves, stacked vertically.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2014
Zimmer Dental. Incorporated Julie Lamothe, Ph.D. Regulatory Affairs Submissions Manager 1900 Aston Ave. Carlsbad, CA 92008
Re: K134045
Trade/Device Name: Zimmer Zfx Abutment for NobelActive Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosscous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 25, 2014 Received: March 28, 2014
Dear Dr. Lamothe:
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 10 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 classilied (see above) into cither class II (Special Controls) or class III (PMA). it nay 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.
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 or any reading 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
5
Page 2 - Dr.. Lamothe
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Ruma, DDS, MA
Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/6/Picture/2 description: The image shows a logo for Zimmer Dental. The logo consists of a circle with a stylized letter "Z" inside. Below the circle, the word "Zimmer" is written in a bold, sans-serif font. Underneath "Zimmer", the word "dental" is written in a smaller, less bold font.
Indications for Use
510(k) Number (if known):
Device Name: Zimmer Zfx Titanium Abutment for NobelActive Implant System
Indications For Use:
The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a Narrow Platform (NP) Ø 3.5mm or Regular Platform (RP) Ø 3.9mm
X 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)
Sheena A. Green -S 2014.04.25 08:07:15 -04'00'