The Tapered Screw-Vent® X 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. The 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.

Device Description

The Tapered Screw-Vent® X Implant is an endosseous dental implant. The implant is composed of titanium alloy and Trabecular metal. 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. In addition, the implant section is tapered with triple-lead threads. The Tapered Screw-Vent X implants will be offered in two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant will have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate Tapered Screw-Vent P Dental implant. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.

AI/ML Overview

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

This document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific, quantifiable acceptance criteria through performance metrics like sensitivity, specificity, etc. Therefore, the information typically requested in your prompt (such as a table of accuracy metrics, sample sizes for test/training sets for algorithm performance, expert qualifications for ground truth, MRMC studies, standalone performance, etc.) is not present because this type of regulatory submission does not require it.

Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating that the new device has the same intended use and similar technological characteristics as the predicate device(s), and that any differences do not raise new questions of safety or effectiveness. The "study" referenced is primarily non-clinical testing to ensure the device performs appropriately for its indicated use, and clinical studies for safety monitoring.

Here's a breakdown based on the information provided, explicitly stating where typical requested information is not available due to the nature of a 510(k) submission for a dental implant:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) pre-market notification for a dental implant, the "acceptance criteria" are related to demonstrating substantial equivalence rather than performance metrics of an AI/software device. The "performance" is demonstrated through non-clinical compliance and clinical safety without adverse events.

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance / Assessment
Intended Use	Matches Predicate: For use in the maxilla or mandible for immediate loading or for loading after a conventional healing period; to replace one or more missing teeth. Specific guidance for 4.1mmD implants in the posterior region (splinting). (Page 1, 2, 6)
Technological Characteristics	Similar to Predicate: Same internal hex interface, similar lengths/diameters (with some new sizes/omissions compared to predicates), same Titanium 6Al-4V material. Similar collar designs and triple-lead thread patterns. (Page 2)
Surface Characteristics	Similar to Predicate with minor difference: Features MTX Surface and Trabecular Metal™ (tantalum), whereas predicates had MTX, CSTi™, HA Coated, or MP-1® HA Coated. The new device uses MTX and Trabecular Metal™, with MTX exposed on surfaces apical and coronal to the Trabecular Metal. (Page 1 and 2)
Non-Clinical Testing	Compliance with Guidance: Performed following "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Demonstrated appropriate performance for proposed indications. (Page 2)
Clinical Testing (Safety)	No Device-Related Adverse Events Reported: A prospective clinical study (posterior region, 2-week final restoration immediate load, 6-month endpoint) and a longitudinal data collection study (routine placement, normal patients, and elevated risk factors) were conducted. No device-related adverse events reported. (Page 2-3)
Material	Matches Predicate: Composed of Titanium 6Al-4V and Trabecular Metal (tantalum). (Page 1-2)
Surgical Instrumentation & Protocol	Identical to Predicate: Uses identical surgical instrumentation and an identical surgical protocol as the Tapered Screw-Vent® (Predicate 2). (Page 2)

Details on Studies:

2. Sample size used for the test set and the data provenance

Prospective Clinical Study: Mentioned for evaluation within a "controlled population" for 'posterior region only' implantation and 'two week final restoration immediate load protocol with a 6-month end point.'
- Sample Size: Not specified.
- Data Provenance: Prospective. Country of origin not specified, but typically conducted in the country where the sponsor is seeking approval (USA for Zimmer Dental Inc.).
Longitudinal Data Collection Study: Initiated to gather data on "routine placement and functioning within normal clinical conditions." Included "normal patients and subjects with elevated risk factors" (alcoholics, substance abusers, mentally unstable, smokers, osteoporotics, uncontrolled diabetics, parafunctional habits, dental or oral infections, and bone graft patients).
- Sample Size: Not specified.
- Data Provenance: Prospective, ongoing. Country of origin not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A): This type of information is pertinent to studies validating diagnostic or predictive algorithms where a ground truth is established for comparison (e.g., expert consensus on image findings). For a dental implant 510(k), ground truth refers to clinical outcomes (safety, integration, absence of adverse events), which are assessed by treating clinicians and reported, not by a panel of independent experts establishing a "ground truth" for a test set in the same way an AI algorithm might be evaluated.

4. Adjudication method for the test set

N/A: As explained above, an adjudication method in the context of expert consensus for a test set is not performed for this type of device submission. Clinical outcomes are reported from the studies.

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.

N/A: This evaluation method is specific to diagnostic aids (often AI-powered) where human readers (e.g., radiologists) interpret cases with and without algorithmic assistance. This is not relevant to the substantial equivalence demonstration for a dental implant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.

N/A: The device is a physical medical implant, not an algorithm. Standalone performance as described is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the clinical studies, the "ground truth" is implied to be outcomes data related to the safety and performance of the implant in a clinical setting. This would include:
- Absence of device-related adverse events.
- Successful implantation and loading (immediate or conventional).
- Successful functioning over the study period.

8. The sample size for the training set.

N/A: No "training set" in the context of machine learning or AI is mentioned or applicable to this device submission. The device is a physical implant.

9. How the ground truth for the training set was established.

N/A: As there is no training set for an algorithm, this question is not applicable.

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 letter "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and below that, the word "dental" is written in a smaller, serif font.

Zimmer Dental

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

510k No.: K113753

Page No .: . A5-1

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

AUG 30 2012

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

1. Submitter's Information:

Zimmer Dental Inc. Name:

1900 Aston Ave. Address: Carlsbad, CA 92008

760-929-4300 Phone:

Jeremy Markovich Contact:

Date Prepared: December 19, 2011

1. Device Name: Tapered Screw-Vent®X Implant Trade Name: K112160 510(k) Number: 872.3640 Regulation Number: DZE Classification Code: Device Classification Name: Endosseous Dental Implant

3. Predicate Device(s):

Predicate Device No. 1 Zimmer Dental Tapered Screw-Vent® P Implant Trade Name: 510(k) Number: K101880 872.3640 Requlation Number: Classification Code: DZE Endosseous Dental Implant Device Classification Name:

Predicate Device No. 2 Zimmer Dental Tapered Screw-Vent® Implant Trade Name: System . K011028 / K953101 / K013227 / K061410 / 510(k) Number: K072589 Regulation Number: 872.3640 DZE Classification Code: Endosseous Dental Implant Device Classification Name:

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Page No.

4. Device Description:

The Tapered Screw-Vent X implants will be offered in two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant will have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate Tapered Screw-Vent P Dental implant. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.

5. Indications for Use:

Device Comparison: હ.

The Tapered Screw-VentX implant is substantially equivalent to Zimmer's Tapered Screw-Vent implant. Both implants have the same friction fit internal hexagon connection and use the same prosthetic components to restore the implant. Both implants feature triple lead threads that taper inwardly from the coronal to the apical end of the implant (the overall taper for both of the implants are 2 degrees). Both implants have apical flutes that allow the implant to self tap into the osteotomy. Similar to the Tapered Screw-Vent®, the Tapered Screw-Vent® X is offered in diameters from 4.1, 4.7, and 6.0mmD (Tapered Screw-Vent® is also offered in 3.7mmD) and in lengths 8, 10, 11.5, and 13mmL (Tapered Screw-Vent® is also offered in 16mmL) The Tapered

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Tapered Screw-Vent® X Implant

Page No.

Screw-Vent® X and Tapered Screw-Vent® all use identical surgical instrumentation and an identical surgical protocol.

7. Technological Characteristics

Feature	Subject Device	Predicate Device 1	Predicate Device 2
	Tapered Screw-Vent® X	Tapered Screw-Vent® P	Tapered Screw-Vent®
Implant Interface	Internal Hex	Internal Hex	Internal Hex
Implant Lengths	8, 10, 11.5, 13mm	10, 11.5, 13, 16mm	8, 10, 11.5, 13, 16mm
Implant Diameters	4.1, 4.7, 6.0mm	4.7, 6.0mm	3.7, 4.1, 4.7, 6.0mm
Material	Titanium 6Al-4V	Titanium 6Al-4V	Titanium 6Al-4V
Collars	Machined with grooves ortexture to top withgrooves	Machined with grooves ortexture to top withgrooves	Machined with grooves ortexture to top withgrooves
Thread Pattern	Triple lead threads,pattern tightly spaced &equal; partial cylindertype body	Triple lead threads,pattern tightly spaced &equal; partial cylindertype body	Triple lead threads,pattern tightly spaced &equal
SurfaceCharacteristics	MTX Surfaceand Trabecular MetalTM(tantalum)	MTX Surfaceand CSTiTM coating	MTX Surface, or HACoated, or MP-1® HACoated

8. Non-clinical Testing

Testing was performed following "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Performance testing demonstrated that the device performs appropriately for the proposed indications for use.

9. Clinical Testing

A prospective clinical study was conducted to evaluate the performance of this device within a controlled population that included implantation within the posterior region only and a two week final restoration immediate load protocol with a 6-month end point.

A second, longitudinal data collection study was initiated to gather data on the routine placement and functioning within normal clinical conditions. This population included normal patients and subjects with elevated risk factors that were excluded from the controlled study, such as: alcoholics, substance abusers, mentally unstable, smokers,

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Tapered Screw-Vent®X Implant

510(k) No. K113753 Page No. A5-4

osteoporotics, uncontrolled diabetics, parafunctional habits, dental or oral infections, and bone graft patients.

No device related adverse events were reported in either study to date.

10. Conclusion

Based on our analysis, the device is substantially equivalent to the predicates and it is considered that the new device is as safe and effective for its indications for use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes extending to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

AUG 30 2012

Mr. Jeremv Markovich Seinor Regulatory Affairs Specialist Zimmer Dental, Incorporated 1900 Aston Ave. Carlsbad, California 92008

Re: K113753

Trade/Device Name: Tapered Screw-Vent® X Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 24, 2012 Received: August 27, 2012

Dear Mr. Markovich:

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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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 (reporting or increments 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,

Nh for

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/6/Picture/0 description: The image shows a logo with a stylized letter 'Z' inside a circle. Below the circle, the word 'zimmer' is written in a sans-serif font. Underneath 'zimmer', the word 'dental' is written in a smaller, slightly italicized font.

A4-1

Tapered Screw-Vent® X Implant

Indications for Use

KII3753

510(k) Number (if known):

Device Name: Tapered Screw-Vent® X Implant

Indications For Use:

× 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)

Super Rese

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

510(k) Number: K113753

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.