(140 days)
Not Found
No
The device description and intended use focus on the physical properties and function of a dental abutment for casting, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an abutment for dental implants, used to create customized restorations, not to directly treat a disease or condition.
No
Explanation: The device is an abutment used in dental implant systems for creating customized prostheses, not for diagnosing medical conditions.
No
The device description explicitly states the abutment is composed of Gold Alloy and 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: The intended use is for creating customized dental restorations (crowns, bridges, bars) for use within the patient's mouth, attached to dental implants. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a physical component (an abutment) made of gold alloy and titanium, designed to be surgically implanted and then used as a base for casting dental prostheses. It does not interact with biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or conditions. Its function is purely mechanical and structural.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging, is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration.
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The purpose of an abutment with Cast-to capabilities is to satisfy customer needs of attaching cast framework prostheses to an abutment. The nonengaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The engaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast a single abutment for a cement-retained crown or bridge and frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System is designed for use with Zimmer 3.1mmD Dental Implant System to support cast framework prostheses. The engaging abutment/implant interface is an internal conical connection with a hex. The non-engaging abutment/implant interface is a connection that sits on top of the implant but does also has cylindrical features that sit passively within the implant.
The abutment is composed of Gold Alloy 6019 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
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. 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 and ISO 14801:2007 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants. The testing indicates that the subject device is substantially equivalent to the predicate device in terms of static and fatigue testing.
In addition, the Zimmer Cast-to Gold Abutments for the 3.1mmD Dental 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°.
The Biocompatibility of the raw material and manufacturing process testing of Gold Alloy 6019 was previously conducted, documented and cleared in the predicate submission (K011028). Biocompatibility testing was completed in compliance to ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.
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 and ASTM F 2182: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging. The results of these tests support the MR conditional labeling of this device.
No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2015
Zimmer Dental Inc. Ms. Christina Boydston Regulatory Affairs Manager 1900 Aston Ave. Carlsbad, California 92008
Re: K143528
Trade/Device Name: Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 2, 2015 Received: April 3, 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.
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 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
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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 is a blue Z inside of a circle, with the words "zimmer dental" below it. The words "Indications for Use" are in black and are in a larger font than the words "zimmer dental."
510(k) Number (if known): K143528
Device Name: Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
Indications For Use:
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging, is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration.
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.
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 arlsbad, CA 92008 60.929.4300 (ph) 60.431.7811 (fax)
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
K143528
1. Submitter's Information:
| Name: | Zimmer Dental Inc. | ||
|---|---|---|---|
| Address: | 1900 Aston Ave. | ||
| Carlsbad, CA 92008 | |||
| Phone: | 760-929-4300 | ||
| Contact: | Christina Boydston | ||
| Date Prepared: | April 29, 2015 |
-
- Device Name: Trade Name:
Regulation Number: Classification Code: Classification: Device Classification Name: Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System 872.3630 NHA II Abutment, Implant, Dental, Endosseous
- Device Name: Trade Name:
3. Predicate Device(s):
| Predicate Device No. 1 | |
|---|---|
| Trade Name: | "Cast-To" Gold Abutments, Engaging |
| 510(k) Number: | K011028 |
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Abutment, Implant, Dental, Endosseous |
Predicate Device No. 2 Trade Name: "Cast-To" Gold Abutments, Non-Engaging 510(k) Number: K011028 872.3630 Regulation Number: Classification Code: NHA Device Classification Name: Abutment, Implant, Dental, Endosseous
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4. Device Description:
The purpose of an abutment with Cast-to capabilities is to satisfy customer needs of attaching cast framework prostheses to an abutment. The nonengaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The engaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast a single abutment for a cement-retained crown or bridge and frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System is designed for use with Zimmer 3.1mmD Dental Implant System to support cast framework prostheses. The engaging abutment/implant interface is an internal conical connection with a hex. The non-engaging abutment/implant interface is a connection that sits on top of the implant but does also has cylindrical features that sit passively within the implant.
The abutment is composed of Gold Alloy 6019 and secured to the implant with a separate Titanium alloy screw for retention.
న్. Indications for Use:
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging, is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration.
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.
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6. Device Comparison:
Differences in technological characteristics between the subject and predicate device did not raise different questions of safety and effectiveness, and that mechanical testing was used to support a conclusion of substantial equivalence (please see non-clinical testing section for details). The subject abutment is substantially equivalent to the predicate relative to material, general design features as well as design and manufacturing process. It is fabricated from Gold alloy. The differences are the implant/abutment interface and platform sizes. The subject abutment and base device will be affixed to the implant by a retaining screw, the same manner as the predicate.
| Feature | Subject Device 1
Zimmer Cast-to Gold
Abutment for the
3.1mmD Dental Implant
System, Engaging | Predicate 1
"Cast-To" Gold
Abutments, Engaging
K011028 | Subject Device 2
Zimmer Cast-to Gold
Abutment for the
3.1mmD Dental Implant
System, Non-Engaging | Predicate 2
"Cast-To" Gold Abutments,
Non-Engaging
K011028 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Material | Gold Alloy 6019 | Gold Alloy 6019 | Gold Alloy 6019 | Gold Alloy 6019 |
| Implant
Interface | Internal Hex
Conical Connection | Internal Hex | Non-engaging conical
connection | Non-hex connection that sits
on the top of the implant |
| Platforms | 2.9mm | 3.5mm, 4.5mm,
5.7mm | 2.9mm | 3.5mm, 4.5mm |
| Maximum
Abutment
Angulation | 30° | 30° | 30° | 30° |
| Method of
Attachment | Retaining screw | Retaining Screw | Retaining screw | Retaining Screw |
| Retaining
Screw | Cat. No. CUAS
Cat. No. CASLC | Cat. No. MHLAS
Cat. No. MTWSD | Cat. No. CUAS | Cat. No. MHLAS |
7. Technological Characteristics
8. Non-Clinical Testing:
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 and ISO 14801:2007 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants. The testing indicates that the subject device is substantially equivalent to the predicate device in terms of static and fatigue testing.
6
In addition, the Zimmer Cast-to Gold Abutments for the 3.1mmD Dental 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°.
The subject abutment will be manufactured using biocompatible material. The subject abutment will be manufactured using the same material as the predicate which were cleared in K011028; therefore, no additional biocompatibility testing was performed on the subject device. The Biocompatibility of the raw material and manufacturing process testing of Gold Alloy 6019 was previously conducted, documented and cleared in the predicate submission (K011028). Biocompatibility testing was completed in compliance to ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.
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 and ASTM F 2182: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging. The results of these tests support the MR conditional labeling of this device.
9. Clinical Testing
No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.
10. Conclusion
The subject device, Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System are gold alloy, abutments with an engaging or non-engaging interface and are designed to provide support for a cast framework.
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System is equivalent to predicate devices in general abutment design, manufacturing process, material, indications, mechanical performances, and risk. The subject devices are Magnetic Resonance Imaging (MRI) compatible conditionally with respect to patient safety.
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System will be manufactured from the same biocompatible material (Gold Alloy 6019) as predicate devices, will be manufactured and inspected according to approved engineering drawings, and Zimmer Dental procedures, and will be packaged in a similar manner as the predicate devices. The subject devices will be sold non
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sterile and will be labeled as "non-sterile", and is intended to be sterilized by the end user. The sterilization procedures were validated to provide a minimum sterility assurance level of 10-6.
Based on the above analysis and the 510(k) submission for Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, the subject device is substantially equivalent to the predicate