The 3.0mm One-Piece Implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The 3.0mm One-Piece implant must be splinted if two or more are used adjacent to each other. The 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Device Description

The Zimmer One-Piece Implant, 3.0mm, Angled is a one-piece endosseous 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 implantation and with facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device (Zimmer® One-Piece Implant, 3.0mm, Angled) and details its equivalence to already marketed predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of performance metrics that would typically be associated with AI/ML medical devices (sensitivity, specificity, etc.).

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. The "device performance" in this context refers to its ability to function as intended, similar to the predicate devices, and its safety and effectiveness.

Here's a breakdown of why the requested information cannot be fully provided based on the input:

Acceptance criteria and reported device performance (Table):
- The document does not explicitly list quantitative acceptance criteria (e.g., specific accuracy thresholds) for the device's performance in the way an AI/ML study would.
- The "device performance" is primarily established through a comparison to predicate devices, asserting that the new device is "equivalent in design" and uses the "same materials, general structure, and function" as the predicate cleared in K052997, particularly noting a dimensional modification (17-degree angle).
- No specific performance metrics like sensitivity, specificity, F1-score, or similar clinical performance measures are reported.
Sample size for the test set and data provenance:
- Not applicable in this document. This is a pre-market notification for a physical medical device, not a study evaluating an AI/ML algorithm on a dataset. The "test set" would be implied through mechanical testing or clinical use (which might be covered in separate studies not included here or prior for the predicate devices).
Number of experts used to establish ground truth and qualifications:
- Not applicable. Ground truth, in the context of an AI/ML study, refers to the definitive correct answer for a given input (e.g., disease presence). For a physical implant, "ground truth" relates to its engineering specifications, biocompatibility, and functional integrity, which are established through manufacturing controls, material science, and prior clinical experience with similar devices.
Adjudication method:
- Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- Not applicable. This is not an AI/ML device; it's an endosseous dental implant.
Standalone performance (algorithm only):
- Not applicable. This is not an algorithm.
Type of ground truth used:
- For a physical medical device like this, the "ground truth" for its safety and effectiveness is established through adherence to design specifications, material standards, biocompatibility testing, mechanical stress testing, and clinical data (often from predicate devices or general clinical experience with similar implant types). The document implies that the device conforms to established standards and performs comparably to the predicate.
Sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not contain the type of AI/ML-specific performance metrics, study design, or data-related information requested. The "proof" is the comparison to existing, already cleared devices.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for Zimmer Dental. The logo consists of a large, stylized letter Z inside a circle, followed by the word "zimmer" in a smaller font. Below "zimmer" is the word "dental" in an even smaller, italicized font.

Zimmer Dental
1900 Aston Avenue

Carisbad, CA 92008 760 929 4300 (ph)

760.431.7811 (fax)

510k No .: K07123

12.7-1

MAY $ 0 2007 Special 510(k): Device Modification PRE-MARKET NOTIFICATION 510(k)

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

Submitter's Information: پسپ

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.
	Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	William Fisher
Date Prepared:	May 2, 2007

Zimmer® One-Piece Implant, 3.0mm, Angled Device Name: ನು
Device Classification Name: Endosseous Dental Implant

Predicate Device(s): Zimmer® One-Piece Implant, 3.0mm, Straight 3. (cat, no. ZOP37S13) Zimmer® Screw Vent® Mini™ 3.3mm (cat. no. SVMB13) + Zimmer® Contour Hex-Lock™ Abutment, 3.5mm (cat. no. ZOA342A)

Device Description: 4.

The Zimmer One-Piece Implant, 3.0mm, Angled is a one-piece endosseous r no Limplant 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 implantation and with facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.

1. Intended Use:
  The 3.0mm One-Piece Implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central nxed single tooth and maxillary lateral incisor regions of partially edentulous and lateral moloor and handlery plant must be splinted if two or more are used jaws. The U.Omin One TTbe 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

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

の 2017年 10:00 【 10:00 【 10:00 【 10:00

Device Comparison: ଚ.

The new device is equivalent in design with Predicate. The new device is The new device to oquiration to the Predicate cleared in K052997. It differs a ulmentsional modifion to abutment portion of the new device is angled from the Predicato in the materials, general structure, and function in the by 17 degrees. The matonale, goins the same as the Predicate Device. enoosseous implant of the same bone tap, drills, and driver as Predicate. The new implant allinessence is used as listed in K052997 previously cleared. It has a matching angled implant try-in

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2007

Mr. William Fisher Regulatory Affairs Associate Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008

Re: K071235

Trade/Device Name: Zimmer® One-Piecc Implant, 3.0mm, Angled Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 02, 2007 Received: May 03, 2007

Dear Mr. Fisher:

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 Eederal Register.

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Page 2 - Mr. Fisher

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 sct 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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sudite y. Michie Oms.

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

K071235 510(k) Number (if known):

Device Name: Zimmer® One-Piece Implant, 3.0mm, Angled

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)

Keir Mulvey for MSR

n of Anesthesiology, General Hospital, on Control, Dental Devices

Number: K071235

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.