The Zimmer Dental Tapered Screw-Vent®T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed 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 Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are a self-tapping, screw type endosseous dental implant designed for bone level placement and can be used in a single or two stage protocol. The implant is composed of titanium alloy with hydroxylapatite (HA) coating, and has a tapered body with an external triple lead thread design. Identical to predicate #1, the new device has the same implant to abutment internal hex friction-fit connection. The new device will have coronal microgrooves that extend to the collar within 0.64mm of the top of the implant identical to predicate #2.

The new implant will be offered in two surface finish configurations at the coronal end: full MTX texturing to the top of the implant and partial MTX texturing to 0.5mm from the top of the implant leaving a machined collar. Both coronal configurations are identical to the currently marketed predicate #2 device (K101977, K111889).

The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated family is composed of tapered implants with a choice of diameters and lengths. Both implant configurations, machined and fully textured collar, will be available in diameters of 3.7mm, 4.1mm, 4.7mm, and 6.0mm and in five lengths: 8, 10, 11.5, 13, and 16mm. 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 drilling sequences and drills that will be utilized to place the new device are pre-existing sequences and drills that are listed in the previous 510(k) K011028.

AI/ML Overview

The provided document describes a pre-market notification (510(k)) for dental implants. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be typical for AI/Software as a Medical Device (SaMD).

Instead, this K133339 submission focuses on demonstrating substantial equivalence of a new dental implant (Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated) to existing predicate devices already on the market.

Therefore, many of the requested criteria in your prompt are not applicable to this type of medical device submission.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not specify performance-based acceptance criteria (e.g., accuracy, sensitivity, etc.) because it is for a physical dental implant, not AI/SaMD. The "acceptance criteria" here are related to demonstrating substantial equivalence in terms of design, materials, indications for use, and mechanical performance compared to predicate devices.

The non-clinical testing sections hint at the performance criteria:

Acceptance Criteria Category	Reported Device Performance
Fatigue Testing	Withstands anticipated forces; demonstrated improvements over predicate device.
Compression Testing	Withstands anticipated forces; demonstrated improvements over predicate device.
MRI Safety & Compatibility	Evaluated for interactions with magnetic fields during MRI in accordance with FDA Guidance.
Substantial Equivalence	Demonstrated through comparison of implant interface, lengths, diameters, material, surface body characteristics to predicate devices.

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

For the non-clinical mechanical testing (fatigue and compression), the document does not specify the sample size used. It only states that "Non-clinical test data was used to support the decision of substantial equivalence." Details like the number of implants tested or the specific test conditions (e.g., cycles for fatigue) are not provided in this summary.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for this type of mechanical device testing.

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

This is not applicable. The "ground truth" for mechanical testing of implants involves engineering specifications and performance standards, not expert clinical interpretation.

4. Adjudication method for the test set

Not applicable for mechanical testing.

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

Not applicable. This is a physical dental implant, not an AI/SaMD. No MRMC study was conducted.

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

Not applicable. This is a physical dental implant, not an algorithm.

7. The type of ground truth used

For the mechanical tests (fatigue and compression), the "ground truth" would be established by specified engineering standards and regulatory guidance documents (e.g., FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). For MRI safety, it relates to the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/SaMD.

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

Not applicable. There is no training set as this is not an AI/SaMD.

In summary:

This 510(k) submission primarily relies on demonstrating substantial equivalence to already legally marketed devices through:

Design comparison: Showing the new device has the same fundamental technology, materials, and intended use as predicate devices. The key differences (coronal microgrooves, surface finish configurations) were shown to be identical to different aspects of existing predicate devices.
Non-clinical testing: Mechanical tests (fatigue and compression) and MRI compatibility were performed to ensure the new device meets established performance standards and is safe. The document states these tests "demonstrated improvements over the predicate device" in mechanical strength, suggesting the new design's modifications did not negatively impact performance and might have enhanced it.
No clinical testing: The submission explicitly states, "No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence." This is common for devices demonstrating substantial equivalence where the risks are well understood and adequately addressed by non-clinical means.

Summary

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K133339

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

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

Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated

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

1. Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.Carlsbad, CA 92008
Phone:	760-929-4366
Contact:	Julie Lamothe Corman

Date Prepared: January 28, 2014

1. Device Name:
  Trade Name:

Regulation Number: Classification Code: Device Classification Name:

Predicate Device(s):

Predicate Device No. 1 Trade Name:

510(k): Classification Code: Device Classification Name:

Predicate Device No. 2 Trade Name:

510(k): Classification Code: Device Classification Name: Zimmer Dental Tapered Screw Vent® T Implant, HA Coated Zimmer Dental Tapered Screw Vent® M Implant, HA Coated 872.3640 DZE Implant, Endosseous, Root-Form

MAR 0 4 2014

Zimmer Dental Tapered Screw Vent® Implant, HA Coated K013227, K061410 DZE Implant, Endosseous, Root-Form

Zimmer Dental Tapered Screw Vent® T Implant Zimmer Dental Tapered Screw Vent® M Implant K101977, K111889 DZE Implant, Endosseous, Root-Form

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4. Device Description:

న. Indications for Use:

The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed 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.

6. Device Comparison:

The new device is equivalent to Predicate #1: Tapered Screw-Vent® family implants (K061410) in implant/abutment connection, implant body design, materials, indication, surface coating, implant sizes and manufacturing

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processes. The only difference in the new design is the coronal section of the device, which is identical to Predicate #2: Tapered Screw-Vent® T Implant and Tapered Screw-Vent® M Implant (K101977, K111889); machined or MTX textured.

The new implant line will be offered in identical length and diameters to predicate #1.

7. Technological Characteristics

Feature	New Device:Zimmer Dental TaperedScrew-Vent' T Implant,HA Coated and ZimmerDental Tapered Screw-Vent' M Implant, HACoated	Predicate Device 1:Zimmer Dental TaperedScrew-Vent' Implant,HA Coated Surface	Predicate Device 2:Zimmer Dental TaperedScrew-Vent' T Implant andZimmer Dental TaperedScrew-Vent' M Implant
Implant Interface	Internal Hex	Internal Hex	Internal Hex
Implant Lengths	8mm, 10mm, 11.5mm,13mm, 16mm	8.0mm, 10mm, 11.5mm,13mm, 16mm	8mm, 10mm, 11.5mm,13mm, 16mm
Implant Diameters	3.7mm, 4.1mm, 4.7mm,6.0mm	3.7mm, 4.1mm, 4.7mm,6.0mm	3.7mm, 4.1mm,4.7mm, 6.0mm
Material	Titanium 6Al-4V	Titanium 6Al-4V	Titanium 6Al-4V
Surface Body Characteristics	HA Coating	HA Coating	MTX Surface

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. The testing indicates that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device.

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.

9. Clinical Testing:

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No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.

1. Conclusion:
  Based on our analysis, the device is substantially equivalent to the predicate.

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Public Health Service

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

March 4, 2014

Zimmer Dental Incorporated Ms. Julie Lamothe Corman Regulatory Affairs Manager 1900 Aston Avenue Carlsbad. CA 92008

Re: K133339

Trade/Device Name: Zimmer Dental Tapered Screw Vent® T Implant, HA Coated Zimmer Dental Tapered Screw Vent® M Implant, HA Coated Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 28, 2014 Received: January 30, 2014

Dear Ms. Corman:

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 markcted 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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,

ErinFDAKeith-S

Erin I. Keith, M.S. Acting 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/6/Picture/2 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, sans-serif font.

Indications for Use

K133339 510(k) Number (if known):

Device Name: Zimmer Dental Tapered Screw-Vent T Implant, HA Coated Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated

Indications For Use:

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 Runner
Mary S. Runner -S
DISM 2014.02.27
14:15:56 -05'00'

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.