(197 days)
Not Found
No
The summary describes a patient-specific dental abutment manufactured based on design parameters and customer modifications, not through AI/ML algorithms. There is no mention of AI, ML, or related concepts in the document.
No.
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is an abutment for a dental implant, which is a restoration device and does not treat or cure a disease.
No
Explanation: The Zimmer® Patient Specific Abutment is a dental implant abutment used as a terminal or intermediate abutment for a cemented prosthesis. Its purpose is to support single or multi-tooth restorations, not to diagnose a condition.
No
The device description explicitly states the abutment is composed of Titanium alloy and is a physical dental implant component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to serve as a terminal or intermediate abutment for a cemented prosthesis in dental restorations. This is a structural component used in vivo (within the body).
- Device Description: The description details a physical implant component made of titanium alloy, designed to connect to a dental implant. It is a mechanical device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in a laboratory setting for diagnostic purposes.
The device is clearly a dental implant component used for structural support in a patient's mouth, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zimmer® Patient Specific Abutment 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® Patient Specific Abutment, Internal Hex, Titanium is designed for use with internal hex connection implants to support single or multi tooth restorations. The abutment/implant interface is an internal hexagonal connection. The proposed changes to the Zimmer Patient-Specific Abutment include changes to the design parameters with respect to the margin width and radius, the cuff height and the cuff width. The updated design parameters do not affect the device's intended use or alter the fundamental scientific technology of the device.
The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is a patient specific dental implant abutment. The purpose of a Patient-Specific abutment is to satisfy patient's 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 abutment is offered in 3.5mm, 4.5mm, and 5.7mm implant platforms.
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
Dentist/Laboratory technician(s)
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 in K071439. 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 testing was previously reviewed and accepted under K071439.
In addition, the Zimmer® Patient Specific Abutment, Internal Hex, Titanium 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus symbol is a common symbol for healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2015
Zimmer Dental, Inc. Ms. Christina Boydston Regulatory Affairs Manager 1900 Aston Ave. Carlsbad, California 92008
Re: K143505
Trade/Device Name: Zimmer® Patient Specific Abutment, Internal Hex, Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 25, 2015 Received: March 27, 2015
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.
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
1
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 devicerelated 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 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.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 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.
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
Enclosure
2
Image /page/2/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a blue circle with a white "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, with the word "dental" written in a smaller font below a horizontal line.
Indications for Use
510(k) Number (if known): K143505
Device Name: Zimmer® Patient Specific Abutment, Internal Hex, Titanium
Indications For Use:
The Zimmer® Patient Specific Abutment 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 900 Aston Avenue rlsbad, CA 92008 60.929.4300 (ph) 60.431.7811 (fax)
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: | December 8, 2014 |
-
- Device Name: Trade Name:
Regulation Number: Classification Code: Device Classification Name: Zimmer® Patient Specific Abutment, Internal Hex, Titanium 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:
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: Zimmer® Patient Specific Abutment, Internal Hex, Titanium K071439 872.3630 NHA Abutment, Implant, Dental, Endosseous
Zimmer Zfx Abutment for Nobel Active Implant System K134045 872.3630 NHA Abutment, Implant, Dental, Endosseous
Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System K141544 872.3630
4
Classification Code: Device Classification Name: NHA Abutment, Implant, Dental, Endosseous
4. Device Description:
The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is designed for use with internal hex connection implants to support single or multi tooth restorations. The abutment/implant interface is an internal hexagonal connection. The proposed changes to the Zimmer Patient-Specific Abutment include changes to the design parameters with respect to the margin width and radius, the cuff height and the cuff width. The updated design parameters do not affect the device's intended use or alter the fundamental scientific technology of the device.
The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is a patient specific dental implant abutment. The purpose of a Patient-Specific abutment is to satisfy patient's 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 abutment is offered in 3.5mm, 4.5mm, and 5.7mm implant platforms.
న్. Indications for Use:
The Zimmer® Patient Specific Abutment 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 proposed changes to the Zimmer® Patient Specific Abutment, Internal Hex, Titanium include changes to the design parameters with respect to the margin width and radius, the cuff height and the cuff width. The updated design
5
parameters do not affect the device's intended use or alter the fundamental scientific technology of the device. Further the updated parameters are similar to the parameters called out for the predicate devices. The new abutment does not change relative to the material, manufacturing process or general design features.
The new abutment device is substantially equivalent to the predicate and remains the same as the current device 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 and the current device. The new abutment will be affixed to the implant by a retaining screw in the same manner as the predicate.
| Feature | New Device
Zimmer® Patient
Specific Abutment,
Internal Hex, Titanium | Existing Device
(K071439)
Zimmer® Patient
Specific Abutment,
Internal Hex,
Titanium | Predicate #2
Zimmer Zfx Titanium
Abutment for
NobelActive Implant
System | Predicate #3
Zimmer Zfx Titanium
Abutment for Biomet 3i
Certain Implant System |
|-------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V |
| Implant Interface | Internal hex,
friction-fit | Internal hex,
friction-fit | Internal Conical,
Internal Hex | Internal Hex |
| Emergence | Contoured/curved
depending on anatomy | Contoured/curved
depending on anatomy | Contoured/curved
depending on anatomy | Contoured/curved
depending on anatomy |
| Margin | Pre-machined | Pre-machined | Pre-machined | Pre-machined |
| Platform Diameter | 3.5mm, 4.5mm,
5.7mm | 3.5mm, 4.5mm,
5.7mm | 3.5mm, 3.9mm | 3.4mm, 4.1mm,
5.0mm, 6.0mm |
| Cuff Width | 3.5mm Platform: 3.5-
9.0
4.5mm Platform: 4.5-
10.0
5.7mm Platform: 5.7-
12.0 | 3.5mm-8.0mm | 3.5mm Platform: 3.0-
9.0
3.9mm Platform: 3.4-
9.0 | 3.4mm Platform: 3.4-
8.0
4.1mm Platform: 4.1-
9.0
5.0mm Platform: 5.0-
10.0
6.0mm Platform: 6.0-
12.0 |
| Cuff Height
(note: screw must be
covered) | No limit | 0.5mm-6.0mm | No limit | No limit |
| Cone Angle | 0°-30° | 0°-30° | 0°-25° | 0°-30° |
| Retaining Screw | MHLAS | MHLAS | ZFX09000627,
ZFX09000628 | ZFX09000978 |
6. Technological Characteristics
6
8. Non-Clinical Testing:
Non-clinical test data was used to support the decision of substantial equivalence in K071439. 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 testing was previously reviewed and accepted under K071439.
In addition, the Zimmer® Patient Specific Abutment, Internal Hex, Titanium 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.
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 and the intended uses have not changed from the previously cleared device submitted under K071439.