The XP1 Angled Abutment is intended for use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. The angled abutment is indicated in cases where angle correction is required.

Device Description

The XP1 15° Angled Abutment is intended to be placed into a dental implant to support prosthetic restorations in partially or fully edentulous mandibles and maxillae. The angled abutment can be used for single or multiple-unit restorations and is intended for cement-retained crowns. The angled abutment is used to correct the prosthetic anqulation of implants that are placed off-axis to the occlusal load.

The distal end of the angled abutment has a hex and taper design that engages the mating internal hex and taper of the implant. In addition, the angled abutment has a screw channel with a screw thread at the distal end through which an abutment screw is used to screw the abutment into the implant.

The XP1 Angled Abutment and the abutment screws are machined from titanium allov (Ti-6AL-4V ELI) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications.

The device is provided non-sterile to the user in medical grade packaging.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the XP1 Angled Abutments, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Composition: Machined from titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F136.	The device is machined from titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Design Principles: Substantially equivalent in design principles to predicate devices.	Keystone Dental, Inc. has demonstrated that the XP1 Angled Abutment is substantially equivalent in design principles to predicate devices. (Implicitly, the FDA's clearance confirms this was met.)
Intended Use: For use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations, where angle correction is required.	The device's stated "Indications for Use" directly matches this criterion. (Implicitly, the FDA's clearance confirms this was met.)

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

The provided document does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for proving the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study on the XP1 Angled Abutments themselves.

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

This information is not applicable as the document does not describe a performance study involving a test set that required expert-established ground truth. The primary method of demonstrating acceptance was substantial equivalence to previously cleared devices.

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

This information is not applicable as the document does not describe a performance study involving a test set that would require an adjudication method.

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

This information is not applicable. The device is an angled dental abutment, a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

The document does not describe a study that required a "ground truth" in the typical sense for analytical or clinical performance evaluations. Instead, the "ground truth" for the device's acceptance was:

Conformance to Industry Standards: The material composition (Ti-6AL-4V ELI conforming to ASTM F136) is a verifiable standard based on material science and engineering specifications.
Substantial Equivalence: The primary "ground truth" for regulatory clearance was a comparison to predicate devices, meaning the regulatory body (FDA) determined the XP1 Angled Abutments were sufficiently similar in design principles, materials, and intended use as devices already legally marketed and deemed safe and effective.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device and does not involve AI or machine learning that would require a "training set."

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

This information is not applicable. The device is a physical medical device and does not involve AI or machine learning that would require a "training set" or its associated ground truth establishment.

Summary of the "Study" for Acceptance:

The submission for the XP1 Angled Abutments (K090397) primarily relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting new clinical trials or extensive performance studies on the new device, the manufacturer demonstrated that the XP1 Angled Abutments were:

Identical or substantially equivalent in intended use.
Identical or substantially equivalent in material composition (Ti-6AL-4V ELI conforming to ASTM F136).
Identical or substantially equivalent in design principles.

The FDA reviewed this comparison and a description of the device's characteristics to determine that it was as safe and effective as the predicate devices already on the market. The letter from the FDA confirms this determination of substantial equivalence, which is the "study" or justification for its acceptance into the market. No specific performance study with a test set, ground truth, or expert involvement as typically understood for software or diagnostic devices is described.

Summary

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Additional Information: K090397

XP1 Angled Abutments

JUN - 5 2009

510(k) Summary

Keystone Dental. Inc. XP1® Angled Abutments

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Keystone Dental, Inc. 144 Middlesex Turnpike Burlington, MA 01803 Telephone: 1 (781) 272-9272 Fax: 1 (781) 272-9972

Official Contact:

Carolyn Bitetti SVP, Quality/Regulatory Keystone Dental. Inc. Direct Line: 781-328-3305 Fax: 781-272-9972 Email: cbitetti@keystonedental.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations: XP1 Angled Abutments Abutment for dental implant Endosseous dental implant abutment (21 CFR 872.3630), Class II NHA

Product Codes

DEVICE CLASSIFICATION PANEL

The Classification Panel for these devices is the Dental Products Panel: the devices are reviewed by the Dental Devices Branch.

INTENDED USE

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DEVICE DESCRIPTION

The device is provided non-sterile to the user in medical grade packaging.

EQUIVALENCE TO ORIGINAL CLEARED PRODUCT

Keystone Dental, Inc. has demonstrated that, for the purposes of FDA's regulation of medical devices, the XP1 Angled Abutment is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three wing-like shapes, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

JUN - 5 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carolyn Bitetti Senior Vice President, Quality/Regulatory Keystone Dental, Incorporated 144 Middlesex Turnpike Burlington, Masachussets, 01803

Re: K090397

Trade/Device Name: XP1 Angled Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 14, 2009 Received: May 15, 2009

Dear Ms. Bitetti:

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 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. Bitetti

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/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Funner

Susan Runner, D.D.S., MA Acting Division 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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K040347

XP1 Angled Abutments

Indications for Use

510(k) Number (if known): K090397

Device Name:

XP1® Angled Abutments

Indications for Use:

Kevin Nale fr MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K090397 510(k) Number:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)