The Tapered Screw-Vent® T 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® T 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. In addition, the implant section is tapered with triplelead threads.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a dental implant, the Tapered Screw-Vent® T Implant. It establishes substantial equivalence to existing predicate devices. However, this document does not describe any study that proves the device meets specific performance acceptance criteria based on metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on:

Device Description: Describing the Tapered Screw-Vent® T Implant's materials (titanium alloy), design features (tapered with triple-lead threads, treated surface for osseointegration), and size offerings.
Indications for Use: Stating that the implants are for use in the maxilla or mandible, for immediate or conventional loading, and to replace one or more missing teeth.
Predicate Device Comparison: Highlighting that the new device is "the same as the predicate Tapered Screw-Vent® Implant in the implant/abutment connection, implant body design, materials, and manufacturing." The only modifications mentioned are the addition of "MTX texture to the top of the implant and add small grooves on the implant collar similar to the predicate NobelReplace Tapered implant."
Substantial Equivalence Determination: The FDA's letter explicitly states that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Therefore, based on the provided text, I cannot provide the requested information regarding acceptance criteria and studies proving performance because:

No Acceptance Criteria or Reported Device Performance Table: The document does not define specific performance metrics (e.g., success rates, complication rates, osseointegration percentages) or acceptance criteria for those metrics. It assumes performance based on substantial equivalence to predicate devices.
No Performance Study Described: There is no mention of a study (clinical or otherwise) designed to measure the Tapered Screw-Vent® T Implant's performance against specific endpoints. The FDA's 510(k) clearance process for this type of device often relies on demonstrating substantial equivalence to already cleared devices rather than requiring new clinical performance studies unless the device raises new questions of safety or effectiveness.

In summary, the provided text does not contain the information required to populate the fields of your request. This 510(k) submission relies on substantial equivalence, not a de novo study demonstrating meeting specific performance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows a 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 lowercase letters, with the word "dental" written in smaller letters underneath and underlined.

Zimmer Dental

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

510k No .:

Page No.:

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

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

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

SFP 1 4 2018

A5-1

Address: 1900 Aston Ave. Carlsbad, CA 92008

760-929-4300 Phone:

Contact: Jeremy Markovich

Date Prepared: July 12, 2010

1. Device Name: Tapered Screw-Vent® T Implant
  Device Classification Name: Endosseous Dental Implant
Predicate Device(s): Zimmer Dental Tapered Screw-Vent® Implant System 3. NobelReplace Tapered Conical Connection
Device Description: 4.

1. Indications for Use:
  The Tapered Screw-Vent® T 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

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

teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

. Device Comparison:

The Tapered Screw-Vent® T Implant is the same as the predicate Tapered Screw-Vent® Implant in the implant/abutment connection, implant body design, materials, and manufacturing. This device has been modified to add the MTX texture to the top of the implant and add small grooves on the implant collar similar to the predicate NobelReplace Tapered 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.

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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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Public Health Service

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

Mr. Jeremy Markovich Regulatory Affairs Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

SEP 1 4 2010

Re: K101977

Trade/Device Name: Tapered Screw-Vent® T Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 3, 2010 Received: September 7, 2010

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 Eederal Register.

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Page 2- Mr. Markovich

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 vours.

1h 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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K101977

Image /page/4/Picture/1 description: The image shows the logo for Zimmer Dental. The logo consists of a stylized letter "Z" inside a circle, with the word "zimmer" written in a bold, sans-serif font below it. Underneath "zimmer" is the word "dental" in a smaller, less bold font. The logo is black and white.

Indications for Use

510(k) Number (if known):

Device Name: Tapered Screw-Vent® T 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)

Susan Runne

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

510(k) Number: K101927

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.