The Tapered Screw-Vent® M Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Device Description

The Tapered Screw-Vent® M Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. The implant contains a 1mm machined collar and small grooves to the top of the implant. In addition, the implant section is tapered with triple-lead threads.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tapered Screw-Vent® M Implant:

This document describes a 510(k) premarket notification for a medical device (dental implant). For such submissions, the primary "acceptance criterion" is Substantial Equivalence to a predicate device, rather than specific performance metrics like sensitivity, specificity, or accuracy which are common for diagnostic or AI-driven devices. Therefore, the information requested in the prompt (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance) is largely not applicable in this context.

The study described is a non-clinical study focused on demonstrating mechanical equivalence, not a clinical study assessing patient outcomes or an AI performance study.

Acceptance Criteria and Reported Device Performance (Non-Applicable for this 510k)

For this 510(k) submission, the "acceptance criteria" and "reported device performance" are framed around demonstrating Substantial Equivalence to legally marketed predicate devices. The core of the "study" is a comparison of technological characteristics and non-clinical mechanical similarity.

Criterion Type	Acceptance Criteria (for Substantial Equivalence)
Primary Goal:	Demonstrate Substantial Equivalence to Predicate Devices
Device Comparison	The Tapered Screw-Vent® M Implant must be shown to be substantially similar to its predicate devices (Tapered Screw-Vent® T Implant and Tapered Screw-Vent® Implant) in:
- Implant/abutment connection	The new device features the "Internal Hex" implant interface, which is identical to both predicate devices.
- Implant body design	The new device has been modified to add a 1mm machined collar and small grooves to the top, and is tapered with triple-lead threads. These features are either identical to or variations seen in the predicate devices (e.g., machined collar similar to Predicate 2, grooves identical to Predicate 1, triple-lead threads same as both predicates). The document states the new device is "mechanically similar" with the "same internal hexagon interface, triple lead threads of the same size and depth, and the same diameter internal thread" as the predicate Tapered Screw-Vent implant.
- Materials	The new device is made of "Titanium 6Al-4V," which is identical to both predicate devices. It is also stated that "Both are fabricated from the same material" (referring to the new device and predicate Tapered Screw-Vent). The new device uses "MTX Surface equivalent to existing Zimmer Dental implants," and the "MTX Surface" is identical across all three devices.
- Manufacturing	The document states, "The Tapered Screw-Vent® M Implant is the same as the predicate Tapered Screw-Vent® T Implant and Tapered Screw-Vent® Implant in the... manufacturing." It also notes that both the predicate Tapered Screw-Vent T and the new device Tapered Screw-Vent M utilize the "same lower level drawing for the machined component."
- Indications for Use	The stated Indications for Use for the new device are consistent with typical uses for endosseous dental implants for which the predicates are used. ("designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load").
Mechanical Equivalence	The Tapered Screw-Vent® M Implant must be shown to be mechanically equivalent to the predicate design, indicating that mechanical testing is not necessary.
	Performance: The device is deemed "mechanically equivalent to the predicate design" due to the shared internal hexagon interface, triple lead threads (same size and depth), same internal thread diameter, same titanium alloy material (with same mechanical properties), and same MTX grit blasted surface (with minor exception of a 0.5mm machined collar finish). This mechanical equivalence means performance is expected to be similar/equivalent to the predicate, making it "as safe and effective for its intended use."

Since this is a 510(k) submission primarily relying on substantial equivalence through design and material comparison, many of the typical questions for AI/diagnostic devices are not applicable.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No formal 'test set' in the sense of patient data for performance evaluation was used. The evaluation was based on design specifications, material properties, and comparison to predicate devices. This is a non-clinical submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. No ground truth was established by external experts for a test set in this context. The "truth" is established by the manufacturer demonstrating equivalence to legally marketed predicates.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication of a test set occurred.
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:
- N/A. This is not an AI device, and no MRMC study was conducted. No human readers or AI assistance are involved in the function or evaluation of this dental implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices. The new device is demonstrated to be substantially equivalent to these predicates based on design, materials, and intended use, eliminating the need for new complex ground truth determination.
The sample size for the training set:
- N/A. No training set was used as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- N/A. No training set or associated ground truth was established.

Summary

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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, with a line underneath it. Below that, the word "dental" is written in a smaller, sans-serif font.

Zimmer Dental

510k No.: K111889

A5-1 Page No .:

DEC - 6 2011

Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)

510(k) SUMMARY (21CFR807.92(a))

1. Submitter's Information:
  Name: Zimmer Dental Inc.

1900 Aston Ave. Address: Carlsbad, CA 92008

Phone: 760-929-4300

Contact: Melissa Burbage

Date Prepared: July 11, 2011

1. Device Name:
  Trade Name: Tapered Screw-Vent® M Implant Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Endosseous Dentai Implant

2. Predicate Device(s):

Predicate Device No. 1 Trade Name: Tapered Screw-Vent® T Implant 872.3640 Regulation Number: Classification Code: DZE Device Classification Name: Endosseous Dental Implant

Predicate Device No. 2
Trade Name:	Tapered Screw-Vent® Implant System
Regulation Number:	872.3640
Classification Code:	DZE
Device Classification Name:	Endosseous Dental Implant

1. Device Description:
  The Tapered Screw-Vent® M Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease of implantation and with greater surface area for

1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

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Page No

osseointegration. The implant section surface is treated to facilitate osseointegration. The implant contains a 1mm machined collar and small grooves to the top of the implant. In addition, the implant section is tapered with triple-lead threads.

ട്. Indications for Use:

റ. Device Comparison:

The Tapered Screw-Vent® M Implant is the same as the predicate Tapered Screw-Vent® T Implant and Tapered Screw-Vent® Implant in the implant/abutment connection, implant body design, materials, and manufacturing. This device has been modified to add the machined collar to the top of the implant similar to the predicate Tapered Screw-Vent implant (K061410) and add small grooves on the implant collar identical to the predicate Tapered Screw-Vent® T implant. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The new implant will be offered in 3.7mm, 4.1mm, 4.7mm and 6.0mm diameters.

Technological Characteristics 7.

Feature	New Device 1Tapered Screw-Vent® M	Predicate Device 1Tapered Screw-Vent® T	Predicate Device 2Tapered Screw-Vent®
Implant Interface	Internal Hex	Internal Hex	Internal Hex
Implant Lengths	8, 10, 11.5, 13, 16mm	8, 10, 11.5, 13, 16mm	8, 10, 11.5, 13, 16mm
Implant Diameters	3.7, 4.1, 4.7, 6.0mm	3.7, 4.1, 4.7, 6.0mm	3.7, 4.1, 4.7, 6.0mm
Material	Titanium 6Al-4V	Titanium 6Al-4V	Titanium 6Al-4V
Collars	Machined surface andtexture, with grooves	Texture to top withgrooves	Machined surface andtexture
Thread Pattern	Triple lead threads,pattern tightly spaced &equal	Triple lead threads,pattern tightly spaced &equal	Triple lead threads,pattern tightly spaced &equal
SurfaceCharacteristics	MTX Surface	MTX Surface	MTX Surface

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Tapered Screw-Vent® M Implant

510(k) No.	K111889
Page No.	A5-2

8. Non-Clinical Testing:

The Tapered Screw-Vent M is mechanically similar to the predicate Tapered Screw-Vent implant; both implants have the same internal hexagon interface, triple lead threads of the same size and depth, and the same diameter internal thread. Both are fabricated from the same material.

Both the predicate, Tapered Screw-Vent T, and the new device, Tapered Screw-Vent M, utilize the same lower level drawing for the machined component which was submitted in K101977. They are both made of titanium allov with the same mechanical properties. Both implants have the same MTX grit blasted surface, with the exception of the 0.5mm wide machined collar finish on the Tapered Screw-Vent M implant. Therefore, the Tapered Screw-Vent M is mechanically equivalent to the predicate design and mechanical testing is not necessary.

റ്റ. Clinical Testing

No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.

1. Conclusion
  Based on our analysis, the device is substantially equivalent to the predicate and considers the new device is as safe and effective for its intended use and performs as well the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Melissa Burbage Manager, Regulatory Affairs Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

DEC - 6 2011

Re: K111889 Trade/Device Name: Tapered Screw-Vent® M Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 17, 2011 Received: October 1, 2011

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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance 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.

Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows a logo for Zimmer Dental. The logo features a stylized letter "Z" inside a circle, with the word "zimmer" in bold, sans-serif font below it. Underneath "zimmer" is the word "dental" in a smaller, sans-serif font.

Indications for Use

510(k) Number (if known):

Device Name: Tapered Screw-Vent® M Implant

Indications For Use:

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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k-111889

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.