ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM
Device Facts
| Record ID | K141544 |
|---|---|
| Device Name | ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM |
| Applicant | Zimmer Dental, Inc. |
| Product Code | NHA · Dental |
| Decision Date | Oct 22, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Indications for Use
The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.
Device Story
Patient-specific dental implant abutment; supports single or multi-tooth cement-retained restorations. Interfaces with Biomet 3i internal connection implants via internal hexagonal connection. Manufactured from Titanium alloy (Ti6Al4V); secured with separate Titanium alloy screw. Custom-fabricated at manufacturing facility to specific patient anatomy; replaces manual chair-side or laboratory modification of stock abutments. Used by dentists/dental technicians in clinical settings. Provides customized emergence profile and margin placement to meet patient-specific restorative needs. Benefits include improved fit and reduced chair-side modification time.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing: reverse engineering of OEM interfaces, tolerance/rotational analysis, and mechanical fatigue testing per FDA guidance for root-form dental implants. Sterilization validated to SAL 10^-6. MRI compatibility evaluated per FDA guidance.
Technological Characteristics
Material: Titanium 6Al-4V. Interface: Internal Hex. Platform diameters: 3.4mm, 4.1mm, 5.0mm, 6.0mm. Cone angle: 0-30°. Sold non-sterile; user-sterilized. Mechanical retention via screw. No software or electronic components.
Indications for Use
Indicated for patients requiring cement-retained dental prostheses supported by Biomet 3i internal connection implants (3.4mm, 4.1mm, 5.0mm, or 6.0mm platforms).
Regulatory Classification
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.
Special Controls
*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.)
Predicate Devices
- Zimmer Zfx Abutment for NobelActive Implant System (K134045)
- Biomet 3i BellaTek Definitive Abutment (K032263/K052648)
- Biomet 3i Certain GingiHue Abutment (K063341)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2014
Zimmer Dental Incorporated Ms. Christina Boydston Quality Manager 1900 Aston Avenue Carlsbad, CA 92008
Re: K141544
Trade/Device Name: Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: September 22, 2014 Received: September 23, 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.
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Page 2 - Ms. Boydston
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,
Susan Runno DDS, MA
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
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Image /page/2/Picture/2 description: The image shows the Zimmer Dental logo on the left and the words "Indications for Use" on the right. The Zimmer Dental logo consists of a stylized blue "Z" inside a circle, with the words "zimmer dental" below it. The words "Indications for Use" are written in a bold, sans-serif font.
K141544 510(k) Number (if known):
## Device Name: Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System
Indications For Use:
The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.
× 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)
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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: | August 6, 2014 | | |
| | | | |
- 2. Device Name: Trade Name:
Regulation Number: Classification Code: Device Classification Name: Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System 872.3630 NHA Abutment, Implant, Dental, Endosseous
- 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 NobelActive Implant System K134045 872.3630 NHA Abutment, Implant, Dental, Endosseous
Biomet 3i BellaTek Definitive Abutment K032263/K052648 872.3630 NHA Abutment, Implant, Dental, Endosseous
Biomet 3i Certain GingiHue Abutment K063341 872.3640 DZE Implant, Endosseous, Root-Form
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#### 4. Device Description:
The Zimmer Zfx Titanium Abutment for the Biomet 3i Certain implant system is designed for use with Biomet 3i internal connection implants to support single or multi tooth restorations. The abutment/implant interface is an internal hexagonal connection.
The Zimmer Zfx Titanium Abutment for Biomet 3i Certain 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 secured to the implant with a separate Titanium alloy screw for retention.
The new abutment will be offered in 3.4mm, 4.1mm, 5.0mm and 6.0mm implant platforms.
## న్. Indications for Use:
The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm or 6.0mm Platform.
## 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 and utilizes an internal hexagonal connection, which is identical in size and shape (for a given platform diameter) to the predicate device. The new abutment and base device will be affixed to the implant by a retaining screw, the same manner as the predicate.
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## Technological Characteristics 6.
| Feature | New Device | Predicate #1 | Predicate #2 | Predicate #3 |
|-------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | Zimmer Zfx Titanium<br>Abutment for Biomet 3i<br>Certain Implant System | Zimmer Zfx Abutment<br>for NobelActive<br>Implant System | Biomet 3i Certain<br>BellaTek Definitive<br>Abutment | Biomet 3i Certain GingiHue<br>Abutment |
| Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium Alloy | Titanium Alloy |
| Implant<br>Interface | Internal Hex | Internal Conical,<br>Internal Hex | Internal Hex | Internal Hex |
| Emergence | Contoured, curved | Contoured, curved | Contoured, curved | Contoured, curved |
| Margin | Pre-machined | Pre-machined | Pre-machined | Pre-machined |
| Platform<br>Diameter | 3.4mm, 4.1mm,<br>5.0mm, and 6.0mm | 3.5mm, 3.9mm | 3.4mm, 4.1mm,<br>5.0mm, and 6.0mm | 3.4mm, 4.1mm, 5.0mm, and<br>6.0mm |
| Cuff Width/<br>Diameter | 3.4-8.0 (3.4 Platform)<br>4.1-9.0 (4.1Platform )<br>5.0-10.0 (5.0 Platform)<br>6.0-12.0 (6.0 Platform) | 3.0mm-9mm (NP)<br>3.4mm-9mm (RP) | 3.8mm-16.0mm | 3.8mm (3.4 platform)<br>5.0mm, 6.0mm, and 7.5mm<br>(4.1, 5.0 platforms)<br>6.0mm and 7.5mm (6.0<br>platform) |
| Minimum<br>Height | 3.0mm MIN Cone<br>3.0mm-12.0mm Overall | 3.0mm MIN Cone<br>3.0mm-12.0mm<br>Overall | 4.75mm-15mm | 7.0mm Cone<br>9.0mm and 11.0mm Overall |
| Cone Angle | 0-30° | 0-25° | 0-30° | 30° |
| Retaining<br>Screw | New device | ZFX0900027 and<br>ZFX09000628 | Cat No. IUNIHG and<br>IUNIHT | Cat No. IUNIHG and<br>IUNIHT |
#### Non-Clinical Testing: 8.
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 Biomet 3i internal connection interface was reverse engineered based on actual measurements taken from Biomet 31 internal connection implants, abutments and retaining screws in order to assure that the Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is compatible with Biomet 3i internal connection Implant Systems. Dimensional specifications were developed for the Zimmer Dental 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 Dental fabricated parts and the OEM implant. To verify the compatibility of the Zimmer Dental device to the OEM device, fatigue testing was completed using Zimmer Dental 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
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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 Biomet 3i Certain Implant System can be deemed compatible with the Biomet 3i internal connection implant interface.
In addition, the Zimmer Zfx Titanium Abutment for the Biomet 3i Certain 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°.
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.
