(162 days)
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No
The 510(k) summary describes a mechanical dental abutment and its physical properties and intended use. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
This device is an abutment for dental implants, which are used in restorative dentistry to replace missing teeth, thereby serving a therapeutic purpose.
No
Explanation: The device is an angled tapered abutment used for dental restorations, specifically to provide angulation correction for off-angle implant placement. Its function is to facilitate the attachment of restorative components and withstand forces, not to diagnose a condition.
No
The device description clearly details a physical, implantable dental abutment made of titanium alloy, including its dimensions, features, and how it is secured. It also mentions a metal delivery tool. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description and intended use of the Angled Tapered Abutment clearly indicate it is a dental implant component used for supporting dental restorations in the mouth. It is a physical device implanted or attached to an implant within the body.
- Lack of Specimen Analysis: There is no mention of collecting, preparing, or analyzing any biological specimens from the patient.
- Focus on Mechanical Function: The description focuses on the mechanical properties, design, and function of the abutment in supporting a dental prosthesis.
- Performance Studies: The performance studies mentioned are non-clinical mechanical tests (fatigue and compression), not studies involving the analysis of biological samples.
Therefore, based on the provided information, the Angled Tapered Abutment is a medical device, specifically a dental implant abutment, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30°Angled Tapered Abutment must be used within 45 degree of parallelism for a splinted restoration. The 15°Angled Tapered Abutment must be used within 30 degrees of parallelism for a splinted restoration.
Product codes
NHA
Device Description
The Angled Tapered Abutment has an external hex which engages the hex of the Tapered Screw-Vent and Screw-Vent implant. The abutments are available in multiple cuff heights and in both 15° and 30° configurations to provide angulation correction for off-angle implant placement. The abutment is secured to the implant with an abutment retaining screw. The abutment screw is preassembled in the abutment and is not removable from the abutment. The abutment has a tapered cone with an internal screw access for the attachment of various restorative components using a separate coping screw. The abutment cone has a 15° taper and is 1.2mm tall. Abutments are packaged with a metal delivery tool to assist with the placement and orientation of the abutment into the implant. The abutment and abutment retaining screw are fabricated from titanium allov.
The current tapered abutments facilitate multiple-unit, screw-retained restoration. These abutments do not engage the internal hex.connection. and are not for use in single-unit. While the current tapered abutments are somewhat limited to straight restoration, the new device will expand the functionality of our screw retained restoration by permitting angled restoration. It will be available in titanium 6Al-4V and will provide an angulation up to 30°.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 safety and effectiveness. 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 device is strong enough to withstand the anticipated forces and demonstrated improvements-over-the-predicate-device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and the word "dental" is written in a smaller, serif font below a horizontal line.
| Zimmer Dental | |
|---|---|
| --------------- | -- |
1900 Aston Avenue
Carlsbad, CA 92008 760.929.4300 (ph)
760.431.7811 (fax)
Device Name: Angled Tapered Abutment
Indications For Use:
The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30°Angled Tapered Abutment must be used within 45 degree of parallelism for a splinted restoration. The 15°Angled Tapered Abutment must be used within 30 degrees of parallelism for a splinted restoration.
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)
Susan Rurr
Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K-111853