Zimmer® One-Piece 3.7mm, Angled implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 3.7mm, Angled implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® One-Piece 3.7mm, Angled implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Device Description

The Zimmer One-Piece Implant, 3.7mm, Angled is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion is angled by 17 degrees. The abutment portion of the implant features a pre-prepared margin to facilitate the restoration process. 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 double-lead threads.

AI/ML Overview

This document (K061717) describes a 510(k) premarket notification for a new dental implant, the Zimmer® One-Piece Implant, 3.7mm, Angled. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics are not available in this document.

Here's an analysis based on the provided text:

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

Not Available. This document does not describe specific performance-based acceptance criteria beyond demonstrating substantial equivalence and meeting general mechanical testing requirements. There are no quantitative performance metrics reported for the device in a clinical context within this submission.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Available. The document states "mechanical testing" was performed to demonstrate substantial equivalence to a predicate device. However, it does not specify the sample size for this mechanical testing, the type of data (e.g., in-vitro, in-vivo), or its provenance. This is a premarket notification, not a clinical trial report.

3. 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)

Not Applicable/Not Available. The concept of "ground truth" established by experts for a test set (as would be relevant in an AI/diagnostic device study) is not applicable here. This submission is for a physical medical device (dental implant) and focuses on mechanical equivalence rather than diagnostic accuracy or expert interpretation of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable/Not Available. As explained above, the type of "test set" and "adjudication" typically associated with AI or diagnostic studies is not relevant to this 510(k) submission for a physical implant.

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 Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. This is a 510(k) submission for a physical dental implant, not an AI or diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this document.

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

Not Applicable. This device is a physical dental implant and does not involve an algorithm, AI, or standalone performance evaluation in the context of a software or diagnostic device.

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

Not Applicable. For this type of device, "ground truth" would typically relate to in-vitro mechanical properties, biocompatibility, and potentially long-term osseointegration and clinical outcomes from existing data on similar devices or post-market surveillance. The document focuses on showing mechanical substantial equivalence, implying that accepted standards and performance of the predicate devices serve as an indirect "ground truth" for the new device's expected physical behavior. No specific "ground truth" methodology as used in diagnostic studies is described.

8. The sample size for the training set

Not Applicable. This document describes a physical medical device (dental implant), not a machine learning model or AI system that requires a "training set."

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

Not Applicable. As there is no "training set" for this physical device, the establishment of ground truth for such a set is not relevant.

Summary of available information from the document:

The document, K061717, is a Special 510(k) for a device modification: the Zimmer® One-Piece Implant, 3.7mm, Angled.
Device Description: It's a one-piece endosseous dental implant made of titanium alloy with an angled (17 degrees) abutment portion. The implant section is designed for osseointegration with a treated surface and tapered, double-lead threads.
Intended Use: Support and retention of fixed single tooth and fixed partial denture restorations in specific regions of partially edentulous jaws. It can be immediately loaded in the anterior mandibular arch if four are splinted and immediately restored with a temporary prosthesis not in functional occlusion.
Substantial Equivalence: The device is deemed substantially equivalent based on mechanical testing comparing it to the Zimmer® Screw Vent® Mini™/ Contour Hex-Lock™ Abutment, 3.5mm, Angled assembly and the Zimmer® One-Piece, 3.7mm, Straight implant. The primary difference is a dimensional modification (17-degree angle), while materials, general structure, and function remain the same as the predicate device.

In essence, this 510(k) relies on demonstrating that the new angled version is mechanically equivalent to existing, legally marketed predicate devices, and therefore does not require a new extensive clinical study with the type of acceptance criteria and performance data requested above.

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 lowercase, sans-serif font. Below the word "zimmer", the word "dental" is written in a smaller, sans-serif font.

Zimmer Dental

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

510k No.: K061717

Page No.: 12.7-1

SEP - 8 2006

Special 510(k): Device Modification PRE-MARKET NOTIFICATION 510(k)

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

1. Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.
	Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	Erin L. McVey
Date Prepared:	June 16, 2006

1. Device Name: Zimmer® One-Piece Implant. 3.7mm. Angled
  Device Classification Name: Endosseous Dental Implant
1. Predicate Device(s): Zimmer® One-Piece Implant, 3.7mm, Straight (cat. no. ZOP37S13) Zimmer® Screw Vent® Mini™ 3.7mm (cat. no. SVMB13) + Zimmer® Contour Hex-Lock™ Abutment, 3.5mm (cat. no. ZOA342A)

4. Device Description:

1. Intended Use:
  Zimmer® One-Piece 3.7mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid. and incisor regions of partially edentulous jaws. Zimmer One-Piece 3.7mm implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® 3.7mm One-Piece implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

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12.7-2

Zimmer® One-Piece, 3.7mm, Angled; 510(k) Summary cont'd:

ି. Device Comparison:

The Zimmer® One-Piece, 3.7mm, Angled implant is substantially equivalent to the Zimmer® Screw Vent® Mini™/ Contour Hex-Lock™ Abutment, 3.5mm. Angled assembly as evidenced in mechanical testing. The Zimmer © One-Piece Implant, 3.7mm, Angled is substantially equivalent to the Zimmer® One-Piece, 3.7mm, Straight implant in that it is manufactured from one piece of titanium with the abutment and implant portions combined. The 3.7mm, angled one-piece implant is identical in design as the 3.7mm, straight implant except the abutment portion is angled by 17 degrees. The new device is a dimensional modification. The materials, general structure, and function in the endosseous implant system. remains the same as the 3.7mm, straight one-piece predicate de inp.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Erin McVey Senior Regulatory Affairs Specialist Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

SEP = 8 2006

Re: K061717

Trade/Device Name: Zimmer® One-Piece Implant, 3.7mm, Angled Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 27, 2006 Received: August 8, 2006

Dear Ms. McVey:

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 such 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. McVey

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Chiu Lin, Ph.D.

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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Indications for Use

510(k) Number (if known): ך 7 7 7 7 1 1 6 ט

Device Name: Zimmer® One-Piece Implant, 3.7mm, Angled

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)

on Sign-Cif) on of Anesthesiology, General Hospital, Control, Dental Devices

Number. K 061711

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Page 12.6-1

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.