ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

ANKYLOS® C/X Implants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

Device Description

The ANKYLOS® C/X Implant 6.6 mm represents a line extension of the currently marketed ANKYLOS® C/X Dental Implant System. It is an endosseous dental implant with a length of 6.6 mm and an internal tapered implant-abutment connection. The ANKYLOS® C/X Implant 6.6 mm is machined from Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67 -Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The ANKYLOS C/X 6.6 mm implants are provided in the diameters 3.5 mm, 4.5 mm, and 5.5 mm.

AI/ML Overview

This looks like a 510(k) premarket notification for a dental implant system. Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The application states that the new device, the ANKYLOS® C/X Implant 6.6 mm, is a line extension of an already cleared device and has largely similar characteristics to its predicate device (K083805 - ANKYLOS® C/X Dental Implant System). The primary acceptance criteria for this type of submission are typically demonstrating substantial equivalence to a legally marketed predicate device, especially in terms of safety and effectiveness.

Here's a table based on the provided "Similarities and Differences" section and the described non-clinical performance data to outline the criteria and the device's performance against them:

Acceptance Criteria (based on predicate device)	Reported Device Performance (ANKYLOS® C/X Implant 6.6 mm)
Material Composition: Commercially Pure Titanium (ASTM F67)	Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67) - Meets
Implant-Abutment Connection: Tapered	Tapered - Meets
Implant Design / Thread: Thread design	Thread design - Meets
Delivery: Sterile	Sterile - Meets
Fatigue Resistance: Equivalent to predicate device (K083805) per ISO 14801	Fatigue testing conducted per ISO 14801; results support substantial equivalence. - Meets
Surface Area & Bone-to-Implant Contact: Calculated by CAD data, comparable to predicate device	Calculated by CAD data; results support substantial equivalence. - Meets
Indications for Use: (Specific to 8mm+ implants) Single/two-stage, cemented/removable/screw-retained, immediate placement with adequate primary stability, single/multiple tooth, splintable.	For 8mm+ implants: Identical indications as predicate. For 6.6mm implants: Two-stage surgical procedures, cemented/removable/screw-retained, immediate placement with adequate primary stability, single/multiple tooth, splintable. (Slight difference for 6.6mm in being limited to two-stage, but still "substantially equivalent" in context of safety and effectiveness based on provided data). - Meets
Functional Safety (FMEA): No unacceptable risks	Failure Mode, Effects Analysis (FMEA) performed. No unacceptable risks identified. - Meets

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

Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many implants were used for fatigue testing or CAD analysis. It simply states "Fatigue testing was conducted on the subject ANKYLOS® C/X Implant 6.6 mm in comparison to the predicate device" and "surface area and bone to implant contact have been calculated by CAD data for the ANKYLOS® C/X Implant 6.6 mm and the predicate device, respectively." For a 510(k) submission, especially for a line extension, the focus is often on representative samples demonstrating conformance to standards rather than large statistical cohorts typical of clinical trials.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of mechanical testing (fatigue, CAD), it's highly likely this was laboratory-based, prospective testing rather than clinical data.

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)

This type of submission focuses on non-clinical performance (mechanical testing and CAD analysis). Therefore, no external experts or clinicians were explicitly used to establish ground truth for a "test set" in the way one might for a diagnostic AI device. The ground truth is established by an international standard (ISO 14801) for fatigue testing and engineering principles for CAD analysis, performed by the manufacturer's qualified personnel.

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

None. As explained above, this is a non-clinical, engineering-focused evaluation based on established standards and calculations rather than subjective assessment requiring adjudication.

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 device is a dental implant, which is a physical medical device, not a diagnostic AI system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable and was not performed.

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

No. This is a physical dental implant, not an algorithm or AI system.

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

The ground truth for the non-clinical performance data (fatigue, surface area, bone-to-implant contact) is derived from engineering standards (ISO 14801) and CAD calculations based on the device's design specifications for the implant and comparison to the predicate. The "ground truth" for the FMEA is based on risk analysis methodologies.

8. The sample size for the training set

Not applicable. This device is a physical dental implant. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering principles, material science, and testing, not through training data in the AI sense.

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

Not applicable. As there is no training set for an AI/algorithm, there is no ground truth established for one. The "truth" about the device's functionality is established through its design, material properties, and adherence to performance standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure, with three overlapping profiles facing to the right. The profiles are rendered in a dark color, contrasting with the white background of the seal.

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

August 20, 2014

Dentsply International, Inc. Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, PA 17404

Re: K140347

Trade/Device Name: ANKYLOS® C/X Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE Dated: July 21, 2014 Received: July 23, 2014

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. 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):

Device Name: ANKYLOS® C/X Implant System

Indications for Use:

X = 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)

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SECTION 5. 510(k) SUMMARY

for ANKYLOS® C/X Implant System

Submitter Information: 1.

DENTSPLY International, Inc. 221 West Philadelphia Street, Suite 60 York, PA 17404

Contact Person:	Helen Lewis
Telephone Number:	717-487-1332
Fax Number:	717-849-4343

Date Prepared: February

Device Name: 2.
.
Proprietary Name:
Classification Name: .
CFR Number: ●
Device Class: ●
Product Code: DZE ●

3. Predicate Device:

ANKYLOS® C/X Dental Implant System cleared in K083805 ●
872.3640

. Bicon Implant 4.0 x 5.0 mm cleared in K092035 (Bicon Implants with a 2.5 mm Internal Connection)
ANKYLOS® C/X Implant System

Endosseous dental implant

4. Description of Device:

న. Indications for Use:
ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or twostage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

ANKYLOS® C/X 1mplants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X

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lmplants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

Description of Safety and Substantial Equivalence: 6.

Technological Characteristics.

The material used for the ANKYLOS® C/X Implant 6.6 mm is the same CP Grade 2 titanium material as is used in the legally marketed predicate device, ANKYLOS C/X Dental Implant System (K083805). The proposed devices are similar in terms of design, sizes, indications for use and incorporate the same technological characteristics as the predicate devices (see Table 1).

In order to assure safety of the ANKYLOS® C/X Implant 6.6 mm, a Failure Mode, Effects Analysis has been performed. There were no unacceptable risks regarding the function of the ANKYLOS® C/X Implant 6.6mm.

Non-Clinical Performance Data.

Fatigue testing was conducted on the subject ANKYLOS® C/X Implant 6.6 mm in comparison to the predicate device according to ISO 14801 (Dentistry - Implants -Dynamic fatigue test for endosseous dental implants). Further, surface area and bone to implant contact have been calculated by CAD data for the ANKYLOS® C/X Implant 6.6 mm and the predicate device, respectively. 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 ANKYLOS® C/X Implant 6.6 mm is substantially equivalent to the predicate devices.

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Table 1: Similarities and Differences between the proposed and the predicate devices
	Proposed Device	Predicate Device	Predicate Device
	DENTSPLY ANKYLOS® C/X Implant System	DENTSPLY ANKYLOS® C/X ImplantSystem(K083805)	Bicon Implant 4.0 x 5.0mm(K092035)
Indications for use	ANKYLOS® C/X Implants of 8mm in length or longer are forsingle-stage or two-stage surgical procedures and cemented,removable or screw retained restorations. The ANKYLOS® C/XImplants may be used for immediate placement and function onsingle tooth and/or multiple tooth applications when adequateprimary stability is achievable, with appropriate occlusalloading, in order to restore chewing function. Multiple toothapplications may be splinted.	The ANKYLOS® C/X Implant System isfor single-stage or two-stage surgicalprocedures and cemented or screwretained restorations. The ANKYLOS®C/X Implant System is intended forimmediate placement and function onsingle tooth and/or multiple toothapplications when good primary stabilityis achieved, with appropriate occlusalloading, in order to restore chewingfunction. Multiple tooth applications maybe splinted with a bar.	The Bicon implant is designedfor use in edentulous sites in themandible or maxilla for supportof a complete denture prosthesis,a final or intermediate abutmentfor fixed bridgework or forpartial dentures, or as a singletooth replacement.
	ANKYLOS® C/X Implants of 6.6mm in length are for two-stage surgical procedures and cemented, removable or screwretained restorations. The ANKYLOS® C/X Implants may beused for immediate placement on single tooth and/or multipletooth applications when adequate primary stability is achievable,with appropriate occlusal loading, in order to restore chewingfunction. Multiple tooth applications may be splinted.
MaterialComposition	Commercially Pure Titanium	Commercially Pure Titanium	Titanium Alloy
Implant-AbutmentConnection	tapered	tapered	tapered
ImplantDesign /	Thread	Thread	Plateau Design
Diameter(mm)	3.5/4.5/5.5/6.5	3.5/4.5/5.5/6.5	4 mm
Length (mm)	6.6/8/9.5/11/14/17	8/9.5/11/14/17	5.0
Delivery	sterile	sterile	sterile

Table 1: Similarities and Differences between the proposed and the predicate devices

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.