(85 days)
The Ti Prepable Abutments are designed for use as a terminal or intermediate abutment for cement retained prostheses. It allows for preparation for the crown to be attached. It can be used for a single or multiple-unit restoration. The abutment is intended to be prepared and placed with patient specific margins.
The Prepable Abutment is a titanium alloy post with an unprepared shape that allows for preparation by the end user. The spline tines on the inside of the abutment provide an anti-rotation feature and the abutment is secured with a separate retaining screw.
This document is a 510(k) Pre-Market Notification for a dental device, specifically a "Ti Prepable Abutment" by Zimmer Dental. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting detailed clinical study data with specific acceptance criteria and performance metrics in the way a PMA (Pre-Market Approval) or de novo submission would.
Therefore, the input document does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets them.
Here's why and what information is available:
- 510(k) Focus: The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance data (often non-clinical, such as mechanical testing). It does not usually involve extensive clinical trials with specific performance metrics and acceptance criteria for clinical outcomes like diagnostic accuracy.
- Mechanical Testing Mentioned: The document explicitly states: "Mechanical fatigue testing has demonstrated that the change in retaining screw does not adversely affect the mechanical strength of the implant/abutment assembly." This is a key piece of performance data for a 510(k) in this context, demonstrating that a design change (the retaining screw) does not degrade mechanical performance. However, specific acceptance criteria for this mechanical testing (e.g., "must withstand X cycles at Y load") and the detailed study protocol/results are not provided in this summary.
Therefore, I cannot populate the requested table or answer the questions precisely as formulated because the provided text is a regulatory summary for a 510(k) submission and does not include the detailed clinical study information you're asking for.
If this were a different type of regulatory submission (e.g., for an AI/ML diagnostic device), the requested information would be expected.
Response to your prompt based on the lack of information in the provided document:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not provided in the document.
- Reported Device Performance: "Mechanical fatigue testing has demonstrated that the change in retaining screw does not adversely affect the mechanical strength of the implant/abutment assembly." Specific numerical values or criteria are not given.
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. The document refers to "mechanical fatigue testing," which is likely bench testing, not a clinical test set with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth establishment by experts is not relevant for the type of testing described (mechanical fatigue).
4. Adjudication method for the test set:
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/ML device; it's a mechanical dental abutment. An MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. Not an algorithm/AI device.
7. The type of ground truth used:
- For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks for mechanical strength and fatigue resistance, which are not detailed here.
8. The sample size for the training set:
- Not applicable/Not provided. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
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Image /page/0/Picture/0 description: The image shows a logo with a stylized letter "L" inside a circle at the top. Below the logo, the word "LUBER" is printed in a bold, sans-serif font. Underneath "LUBER", the text "dental" is displayed in a smaller, less bold font. The text in the image appears to be slightly blurred or of low resolution.
Zimmer Dental
510k No.: K092463
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
| Page No.: | A5- |
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| ----------- | ----- |
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
OCT 3 0 2009
510(k) SUMMARY (21CFR807.92(a))
- Submitter's Information: 1.
Zimmer Dental Inc. Name:
1900 Aston Ave. Address: Carlsbad, CA 92008
760-929-4300 Phone:
Larissa D'Andrea McMullin Contact:
Date Prepared: October 23, 2009
- Ti Prepable Abutment 2. Device Name: (cat no. 1618, 1619, 1620)
Device Classification Name: Endosseous Dental Implant
Predicate Device(s): Integral VII 3.25mm Biointegrated Dental Implant System 3. (Fixed Abutment) (1506, 1507, 1508, and 1510)
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Device Description: র্ব .
The Prepable Abutment is a titanium alloy post with an unprepared shape that allows for preparation by the end user. The spline tines on the inside of the abutment provide an anti-rotation feature and the abutment is secured with a separate retaining screw. -
- Intended Use:
The Ti Prepable Abutments are designed for use as a terminal or intermediate abutment for cement retained prostheses. It allows for preparation for the crown to be attached. It can be used for a single or multiple-unit restoration. The abutment is intended to be prepared and placed with patient specific margins.
- Intended Use:
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| 510(k) No. | |
|---|---|
| Page No. | A5-2 |
Device Comparison: 6.
The new device is substantially equivalent to the predicate. The devices, general structure, and function in the endosseous implant system remains the same as the predicate devices. It is fabricated from the same titanium alloy as the predicates and utilizes a Spline 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, the same manner as the predicate; however, the retaining screw utilized is different then that used by the predicate. Mechanical fatigue testing has demonstrated that the change in retaining screw does not adversely affect the mechanical strength of the implant/abutment assembly.
Typically abutments are prepared for use by the clinician or a dental laboratory by removing material from the cone and margin areas. The new abutment differs from the predicate by providing more material that the dental clinician or a dental laboratory can utilize to create a natural prosthetic attachment.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ms. Larissa D'Andrea McMullin Associate Manager, Regulatory Affairs Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008
OCT 3 0 2009
Re: K092403
Trade/Device Name: Ti Prepable Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 1, 2009 Received: August 6, 2009
Dear Ms. McMullin:
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.
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. McMullin
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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Susan Runner, D.D.S., M.A Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ti Prepable Abutment Zimmer Dental
Indications for Use
510(k) Number (if known):
Device Name: Ti Prepable Abutment
Indications For Use:
The Ti Prepable Abutments are designed for use as a terminal or intermediate abutment for cement retained prostheses. It allows for preparation for the crown to be attached. It can be used for a single or multiple-unit restoration. The abutment is intended to be prepared and placed with patient specific margins.
X 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)
Kein Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
Page: Section A4-1
510(k) Number: K092403
§ 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.)