The angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants. Implants may be tilted up to 45°. When used with angulations between 30°and 45° in edentulous arch, a minimum of four implants must be used and splinted.

The straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE®, FRIALIT® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws. immediate loading is possible using a minimum of 4 implants.

Device Description

The Angled XiVE® MP and ANKYLOS® Balance Base Abutment are endosseous dental implant abutments which provide a platform for prosthetic restoration with bridges or bar constructions in conjunction with XiVE and ANKYLOS® implants. The abutments are provided with an angulation of 15° and 30° at gingival heights ranging from 2.0mm - 5.0 mm for angled XiVE® MP abutments and from 3.0mm - 4.5mm for angled ANK YLOS® Balance Base abutments, respectively. The angled ANK YLOS® BalanceBase Abutments are offered in 3.45mm diameter (compatible with all ANKYLOS® implants). The angled XiVE® MP Abutments are offered in diameters ranging from 3.4mm (compatible with 3.4mm diameter XIVE® implants) to 3.8mm (compatible with XiVE® implants of 3.8mm - 5.5mm diameter). The abutments are connected to the corresponding implants by a central screw which mates with the internal thread of the implant. The abutments and the abutment screws are machined from Titanium Alloy (Ti6AL4V ELI) conforming to ASTM F 136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial Alloy for Surgical Implant Applications).

The Angled XiVE® MP and ANKYLOS® Balance Base Abutments facilitate the SmartFixTM treatment concept in which the angled abutments are used in combination with straight abutments on a of minimum four (4) implants (with two posterior implants placed at an angle of up to 45° in the posterior region) to support prosthetic restorations.

In addition to the introduction of the Angled XiVE® MP and ANK YLOS® Balance Base Abutments, a modification to the indications for use statements of the currently marketed straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments is implemented as part of this premarket notification.

AI/ML Overview

The provided text is a 510(k) summary for dental implant abutments and does not contain information about a study that proves the device meets acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) or a clinical trial with human subjects.

Instead, the document details the substantial equivalence of the Angled XiVE® MP and ANKYLOS® Balance Base Abutments to legally marketed predicate devices. The "performance data" mentioned refers to non-clinical, engineering-focused testing, specifically fatigue data, to demonstrate the structural integrity and durability of the device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the type of information presented in this 510(k) summary.

Here's a breakdown of the relevant information from the document as it pertains to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Summary of Non-Clinical Testing)
Material Equivalence: Device material conforms to established standards and is equivalent to predicate device material.	The abutments are machined from Titanium Alloy (Ti6AL4V ELI) conforming to ASTM F 136, which is the same material used in the legally marketed predicate device.
Design and Technological Equivalence: Device design, angulations, sizes, and technological characteristics are similar to predicate devices.	The proposed devices are similar in terms of design, angulations (15° and 30°), sizes (gingival heights 2.0mm-5.0mm for XiVE, 3.0mm-4.5mm for ANKYLOS; diameters 3.45mm for ANKYLOS, 3.4mm-3.8mm for XiVE), and indications for use. They incorporate the same technological characteristics as the predicate devices.
Safety - Risk Assessment: No unacceptable risks identified regarding the function of the device.	A failure mode, effect, and criticality analysis (FMECA) was performed. "There were no unacceptable risks regarding the function of the Angled XiVE® MP and ANKYLOS® Balance Base Abutments."
Mechanical Integrity/Durability: Device can withstand intended forces and has adequate fatigue life.	"Representative fatigue data from testing is included and the results support substantial equivalence." (Specific quantitative acceptance criteria for fatigue and the exact data are not provided in this summary but would have been part of the full submission).
Substantial Equivalence: Demonstrated equivalence to predicate devices based on indications for use, technological characteristics, and non-clinical testing.	"Based on the comparison of the indications for use, the technological characteristics and the non-clinical testing it can be concluded that the Angled XiVE® MP and ANKYLOS® Balance Base Abutment are substantially equivalent to the predicate devices."

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

Test Set Sample Size: Not explicitly stated as this is non-clinical engineering testing (fatigue testing). The "sample size" would refer to the number of abutments tested for fatigue. This information is typically proprietary and not fully disclosed in a public 510(k) summary.
Data Provenance: Not specified, but generally, such engineering tests are conducted in a controlled laboratory environment, often by the manufacturer or a contracted lab. The document does not indicate country of origin of data or whether it was retrospective or prospective, as these terms are not applicable to non-clinical device testing in this context.

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

Not applicable. Ground truth in this context is related to engineering specifications and performance standards (e.g., ASTM standards for materials, recognized test methods for fatigue). Clinical expert consensus is not used to establish this type of "ground truth."

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

Not applicable. Adjudication methods are typically for clinical studies with subjective interpretations. This document describes objective non-clinical performance data.

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. This is a medical device (dental abutment), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

No. This is a physical medical device, not an algorithm.

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

The "ground truth" for this type of submission is based on established engineering standards, material specifications (e.g., ASTM F 136), and recognized test methods for mechanical performance (e.g., fatigue testing protocols). The implicit ground truth is that the device must meet or exceed the performance characteristics of the predicate devices according to these objective engineering metrics.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/machine learning model.

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

Not applicable. There is no "training set" or "ground truth" in the AI/ML sense.

Summary

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X 2268

SECTION 5. 510(k) SUMMARY

Angled XiVE® MP and ANKYLOS® Balance Base Abutments

DEC 1 1 2012

1. Submitter Information:

DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Contact Person:	Helen Lewis
Telephone Number:	717-849-4229
Fax Number:	717-849-4343

November 2, 2012 Date Prepared:

Device Name: 2.
- Proprietary Name: .

Angled XiVE® MP and ANKYLOS® Balance Base Abutments

Endosseous dental implant abutment

Classification Name: CFR Number: .
Device Class: .
Product Code: NHA .

3. Predicate Device:

Angled Multi-Unit Abutments cleared in K050406 (NOBELSPEEDY™ � Implants)
Straight ANKYLOS® Balance Base Abutments cleared in K073075 .

872.3630

(FRIADENT Implant Systems) .
Straight FRIADENT® MP Abutments cleared in K994174 (FRIALIT-2® . MH-2 ABUTMENT)

Description of Device: 4.

Premarket Notification

Angled XiVE* MP and ANKYLOS* Balance Base Abutment

DENTSPLY International

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న. Indications for Use:

The angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants may be tilted up to 45°. When used with angulations between 30°and 45° in edentulous arch, a minimum of four implants must be used and splinted.

6. Description of Safety and Substantial Equivalence:

Technological Characteristics.

The material used for the Angled XiVE® MP and ANKYLOS® Balance Base Abutments, Ti6Al4V, is the same Titanium Alloy material as is used in the legally marketed predicate device. The proposed devices are similar in terms of design, angulations, sizes, indications for use and incorporate the same technological characteristics as the predicate devices.

In order to assure safety of the Angled XiVE® MP and ANKYLOS® Balance Base Abutment, a failure mode, effect and criticality analysis has been performed. There were no unacceptable risks regarding the function of the Angled XiVE® MP and ANKYLOS® Balance Base Abutments.

Non-Clinical Performance Data.

Representative fatigue data from testing is included and the results support substantial equivalence.

Conclusion as to Substantial Equivalence:

Based on the comparison of the indications for use, the technological characteristics and the nonclinical testing it can be concluded that the Angled XiVE® MP and ANK YLOS® Balance Base Abutment are substantially equivalent to the predicate devices.

Angled XiVE* MP and ANKYLOS* Balance Base Abutment Premarket Notification DENTSPLY International

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a title or heading. The font is a serif typeface, and the overall impression is one of official documentation or signage.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 11, 2012

Ms. Helen Lewis Director. Corporate Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60W YORK PA 17404

Re: K122268

Trade/Device Name: Angled XiVE® MP and ANKYLOS® Balance Base Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 2, 2012 Received: November 13, 2012

Dear Ms. Lewis:

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 Federal Register.

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Page 2 - Ms. Lewis

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 or any I vith 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.goy/MedicaiDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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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SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K122268

Device Name: Angled XiVE® MP and ANKYLOS® Balance Base Abutments

Indications for Use:

The straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments are implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants.

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)

2012.12.05 Susan Runner DDS, MA -12:56:50 -05'00'

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

510(k) Number:

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.)