(241 days)
Not Found
No
The summary describes a physical dental abutment system and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
No.
The descriptions indicate that this device is intended for use as a dental abutment for prostheses, which is a structural component of a medical device, not a therapeutic device itself.
No
The provided text describes the Zimmer Zfx Titanium Base Abutment as a dental prosthetic used for restorations (e.g., crowns, bridges). Its purpose is to provide structural support for prostheses, not to diagnose medical conditions or diseases.
No
The device description clearly outlines physical components made of titanium and zirconia, and the performance studies describe mechanical testing of these physical components. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Zimmer Zfx Titanium Base Abutment is a dental implant component used for supporting dental prostheses (crowns, bridges). It is a physical device implanted in the mouth, not a test performed on a biological sample.
- Lack of IVD-related terms: The text does not mention any terms related to testing biological samples, analyzing biomarkers, or diagnosing medical conditions.
- Performance Studies: The performance studies described are mechanical tests evaluating the strength and equivalence of the device to existing dental abutments, not clinical studies evaluating diagnostic accuracy.
Therefore, the Zimmer Zfx Titanium Base Abutment falls under the category of a dental device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single-unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a two piece abutment. The abutment is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment is used for single unit restorations in the anterior and posterior regions. The abutment base will be made available in 3.5, 4.5 and 5.7mm platforms. The Zimmer Zfx Titanium Base serves as a bonding base that allows for cementation of a patient-specific restoration. Copings, crowns and bridges can be used with the Zimmer Zfx Titanium Base.
The Zimmer Zfx Abutment Coping is a zirconia mesostructure component that would be cemented onto the Zimmer Zfx Titanium Base Abutment to form the two-piece abutment. These componenents will be manufactured from zirconia or IPS e.Max. The maximum angulation that is allowed is 20°. The two piece abutment would then be able to be used as a terminal or intermediate abutment for cement or screw retained prostheses that is for a single or multi-unit (bridge) restoration. The Zimmer Zfx Abutment Coping would require a separate crown to be cemented onto the coping or direct veneering to be applied.
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 Testing:
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.
Additionally, in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments, nonclinical mechanical testing of the Zimmer Zfx Titanium Base Abutment was performed. Two different tests were conducted in order to characterize the mechanical strength of the new device. The first test consisted of the Titanium base portion of the new device assembled in a abutment test setup. A hemispherical test cap, representing a final restoration, was cemented directly to the Titanium base portion of the device. The results demonstrated that the Titanium base portion of the new device is equivalent to the currently marketed Zimmer Hex Lock Abutment (K011028). The second test evaluated the new device as a two-piece abutment system. The testing was performed with the Titanium base portion of the new device and a 20 degree angulated Zirconia mesotructure cemented together. The results demonstrated that the two-piece abutment system is substantially equivalent to the currently marketed Zimmer Pre-Angled Ti Abutment (K011028).
Clinical Testing:
In accordance with the FDA guidance Class II Special Controls Guidance Document: Rootform Dental Implants and Endosseous Dental Implant Abutments, clinical testing of the Zimmer Zfx Titanium two piece Abutment was not performed. The device is not significantly different from the predicate device and also contains the same design features, technological characteristics and indications as the currently marketed Zimmer Hex Lock Abutment (K011028).
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.)
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Zimmer Dental
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
JUL 1 8 2014
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: | 760-929-4315 |
| Contacts: | Melissa Burbage |
| Kerry Foote |
Date Prepared: June 13, 2014
-
- Device Name: Trade Name: Regulation Number: Classification Code: Device Classification Name:
Zimmer Zfx Titanium Base Abutment 872.3630 NHA Endosseous Implant, Abutment
- Device Name: Trade Name: Regulation Number: Classification Code: Device Classification Name:
3. Predicate Device(s):
Predicate Device No. 1 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 2 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 3 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name: Hex Lock Abutment K011028 872.3630 NHA Endosseous Implant, Abutment
Zimmer Pre-angled Ti Abutment K011028 872.3630 NHA Endosseous Implant, Abutment
Strauman® Variobase™ Abutments K132219 872.3630 -NHA Endosseous Implant, Abutment
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4. Device Description:
The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a two piece abutment. The abutment is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment is used for single unit restorations in the anterior and posterior regions. The abutment base will be made available in 3.5, 4.5 and 5.7mm platforms. The Zimmer Zfx Titanium Base serves as a bonding base that allows for cementation of a patient-specific restoration. Copings, crowns and bridges can be used with the Zimmer Zfx Titanium Base.
The Zimmer Zfx Abutment Coping is a zirconia mesostructure component that would be cemented onto the Zimmer Zfx Titanium Base Abutment to form the two-piece abutment. These componenents will be manufactured from zirconia or IPS e.Max. The maximum angulation that is allowed is 20°. The two piece abutment would then be able to be used as a terminal or intermediate abutment for cement or screw retained prostheses that is for a single or multi-unit (bridge) restoration. The Zimmer Zfx Abutment Coping would require a separate crown to be cemented onto the coping or direct veneering to be applied.
న . Indications for Use:
The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single-unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.
6. Device Comparison:
The new device is substantially equivalent to the predicate device, in that it is manufactured with the same material, has the same intended use, and contains the same abutment/implant interface design. The function in the endosseous implant system remains the same as the predicate devices. The new device is fabricated from Titanium alloy and utilizes the hex implant/abutment interface, which is identical in size and shape (for a given platform diameter) to the predicate device. The new device will be affixed to the implant by a retaining screw. In addition, the new titanium base is similar to that of the predicate device. The new device will be utilized with the same Zimmer Dental Product Lines as the predicate device. The Zimmer Zfx Titanium Base is designed with a shorter and narrower cone, when compared to the predicate device. By minimizing
2
the size of the cone on the Titanium Base, the amount of metal available to be seen through the final restoration is minimized producing a more aesthetic finish.
7. Technological Characteristics
| Feature | New Device | Predicate 1 | Predicate 2 | Predicate 3 |
|---|---|---|---|---|
| Zimmer Zfx Titanium Base | ||||
| Abutment for Zimmer Tapered | ||||
| Screw-Vent Implant System | Zimmer Hex Lock | |||
| Abutment 510(k) | ||||
| K011028 | Zimmer Pre-Angled Ti | |||
| Abutment | ||||
| K011028 | Strauman® Variobase™ | |||
| Abutments | ||||
| K132219 | ||||
| Indications | The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single-unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility. | For use as a terminal abutment for cemented prosthesis. Abutments are for single unit restorations. Single use. | For use as a terminal abutment for cemented prosthesis. Abutments are for single unit restorations. Single use. | Strauman® Variobase™ Abutments are pre-manufactured (stock) abutments intended to be placed onto Strauman dental implants to provide support for customized prosthetic restorations such as crown and bridges. Strauman® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. |
| Implant | ||||
| Interface | Internal Hex | Internal, Hex | Internal, Hex | Various |
| Abutment | ||||
| Platform | ||||
| Diameter | 3.5mm, 4.5mm, 5.7mm | 3.5mm, 4.5mm, 5.7mm | 3.5, 4.5, 5.7 mm | Various |
| Material | Titanium 6Al-4V (base) | |||
| Zirconia (coping/crown) | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-7Nb (base) | |
| Zirconia/Zerion | ||||
| (coping/crown) | ||||
| Acrylic/polycon | ||||
| (coping/crown) | ||||
| Packaging | PETG tray | Cap/Vial | Cap/Vial | Not identified |
| Compatible | ||||
| with CAD/CAM | ||||
| patient-specific | ||||
| restorations | Yes | Yes | Yes | Yes |
| Compatible | ||||
| with Traditional | ||||
| patient-specific | ||||
| restorations | Yes | Yes | Yes | Yes |
- Non-Clinical Testing:
3
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.
Additionally, in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments, nonclinical mechanical testing of the Zimmer Zfx Titanium Base Abutment was performed. Two different tests were conducted in order to characterize the mechanical strength of the new device. The first test consisted of the Titanium base portion of the new device assembled in a abutment test setup. A hemispherical test cap, representing a final restoration, was cemented directly to the Titanium base portion of the device. The results demonstrated that the Titanium base portion of the new device is equivalent to the currently marketed Zimmer Hex Lock Abutment (K011028). The second test evaluated the new device as a two-piece abutment system. The testing was performed with the Titanium base portion of the new device and a 20 degree angulated Zirconia mesotructure cemented together. The results demonstrated that the two-piece abutment system is substantially equivalent to the currently marketed Zimmer Pre-Angled Ti Abutment (K011028).
Clinical Testing:
In accordance with the FDA guidance Class II Special Controls Guidance Document: Rootform Dental Implants and Endosseous Dental Implant Abutments, clinical testing of the Zimmer Zfx Titanium two piece Abutment was not performed. The device is not significantly different from the predicate device and also contains the same design features, technological characteristics and indications as the currently marketed Zimmer Hex Lock Abutment (K011028).
9. Conclusion:
Based on our analysis, the device is substantially equivalent to the predicate.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle faces to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2014
Zimmer Dental, Inc. Melissa Burbage Associate Director, Regulatory Affairs 1900 Aston Ave. Carlsbad, CA 92008
Re: K133551
Trade/Device Name: Zimmer Zfx Titanium Base Abutments for Tapered Screw-Vent Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 16, 2014 Received: June 18, 2014
Dear Ms. Burbage:
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. Burbage
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.lda.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 Industry and Consumer Education 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,
Image /page/5/Figure/8 description: The image shows the name Tejashri Purohit-Sheth, M.D. twice, along with the acronym FDA in a stylized font. The text below the name indicates that Tejashri Purohit-Sheth, M.D. is a Clinical Deputy Director. The acronym DAGRID/ODE/CDRH is also present, followed by the word 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
Enclosure
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Image /page/6/Picture/2 description: The image shows a logo with the letter "Z" inside a circle at the top. 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): K133551
Device Name: Zimmer Zfx Titanium Base Abutments for Tapered Screw-Vent Implant System
Indications For Use:
The Zimmer Zfx, Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Coping of Crown as part of a straight of a straight of a straight of a straight of a straight of a straight of
the abutment coping is designe cement or screw retained prostheses. The two-piece abutment is used for a single unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility!
Prescription Use _ X (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)
Lauren M. 2014.07.18
Giles-S 15:58:56
-04'00"
for SAG