Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants. Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally.

Device Description

The ANK YLOS® SynCone Abutiment 5° is an endosseous dental implant abutment which provides a platform for prosthetic restoration in conjunction with ANKYLOS™ implants. The subject device incorporates an abutment head with a 5° conical taper and is provided in angulations of 0° 7.5° 15° 22.5° and 30° and with gingival heights ranging from J.5mm . 4.5mm. The abutment is connected to the corresponding iniblant. by a central screw which mates with the internal thread of the implant. The abuiment and the abutment screw are machined from Titanium Alloy (Ti6AL4V ELI) conforming 10 ASTM F136 (Standard Specification for Wrought Titannum-6 Aluminim-4 Vanadium ELI (Extra Low Interstitial' Alloy for Surgical Implant Applications). The tapered SynCone® 5° caps which anchor the SynCone® abutment on the fixed denture are made of Gold Alloy of Titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The SynCone® abutments feature a reatining screw design which allows for the rotation of the abutment head after attachment to the implant in order to achieve rotational alignment for all of the abutments used in the prosthetic restoration.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ANKYLOS® SynCone® Abutment 5°:

Acceptance Criteria and Study Details for ANKYLOS® SynCone® Abutment 5°

Based on the provided 510(k) summary, the device's acceptance criteria and the studies performed focus on demonstrating substantial equivalence to predicate devices. The primary criteria revolve around material composition, design, and performance characteristics compared to existing, legally marketed products.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Performance Target	Reported Device Performance
Material Composition Equivalence	Material for the ANKYLOS® SynCone® Abutments 5° should be the same as in the legally marketed predicate device (Ti6Al4V ELI conforming to ASTM F136). Material for tapered SynCone® 5° caps should be Gold Alloy or Titanium conforming to ASTM F67, equivalent to existing accessory components.	The ANKYLOS® SynCone® Abutments 5° are machined from Titanium Alloy (Ti6Al4V ELI) conforming to ASTM F136, the same as the predicate devices. The tapered SynCone® 5° caps are made of Gold Alloy or Titanium conforming to ASTM F67. Materials of composition for accessory components are equivalent to existing, legally marketed accessory components.
Design Equivalence	Similar in design, angulations, sizes, and incorporate the same technological characteristics as the predicate devices. Design of caps and abutment cover screw corresponds to the abutments.	The proposed devices are "similar in terms of design, angulations, sizes, indications for use and incorporate the same technological characteristics as the predicate devices." The design of the caps and abutment cover screw corresponds to the abutments.
Indications for Use Equivalence	Indications for use are the same as or comparable to predicate devices.	The indications for use are presented as: "Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants." and "Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally." These are considered equivalent in the context of substantial equivalence. A modification to the indications for use of existing ANKYLOS SynCone Abutments 4° and 6° was also implemented.
Biocompatibility	Biocompatibility of materials used in accessory components should be evidenced.	Biocompatibility of accessory components "has been evidenced."
Safety - Failure Mode, Effect, and Criticality Analysis (FMECA)	No unacceptable risks regarding the function of the ANKYLOS® SynCone® Abutments 5°.	A FMECA was performed, and "There were no unacceptable risks regarding the function of the ANKYLOS® SynCone® Abutments 5°."
Fatigue Performance	Meet or exceed predicate device performance when tested according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants).	"Representative fatigue testing was conducted... and the results support substantial equivalence."
Pull Force Retention	Equivalence of taper friction retention properties compared to predicate abutments.	"Pull force testing was conducted to verify the equivalence... The results confirmed the equivalence of the performance of the new 5° abutment with that of the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific numerical sample sizes for the test sets in the non-clinical performance data (fatigue testing, pull force testing). It mentions "Representative fatigue testing" and "Pull force testing."

The data provenance is non-clinical bench testing, meaning it's laboratory-generated data, not from human subjects. Therefore, country of origin and retrospective/prospective designations for human data are not applicable here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable. The ground truth for this type of submission (demonstrating substantial equivalence through non-clinical bench testing) is defined by established international standards (like ISO 14801) and direct comparison to the performance characteristics of legally marketed predicate devices. It does not involve expert adjudication of human clinical data.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation relies on objective measurements from bench testing following established standards and direct comparison to predicate device performance. No human adjudication of results is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The ANKYLOS® SynCone® Abutment 5° is a dental implant abutment, and its evaluation for this 510(k) submission relied on non-clinical performance data.

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

This section is not applicable. The device is a physical medical device (an implant abutment), not an algorithm or AI system. Its performance is inherent in its physical and mechanical properties, evaluated through bench testing, not through an algorithm's output.

7. The Type of Ground Truth Used

The ground truth used for verifying the device's performance is established engineering and material science standards and metrics, and direct comparative performance against legally marketed predicate devices.

Specifically:

ISO 14801: Dynamic fatigue test for endosseous dental implants.
ASTM F136 and ASTM F67: Standard specifications for titanium alloys, defining acceptable material properties.
Performance of predicate devices: The established and accepted performance of the ANKYLOS SynCone® Abutinents 4º and 6° (K041509) and Angled ANKYLOS® Balance Base Abutments (K122268) serve as the benchmark for equivalence.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. A training set is used in machine learning to teach an algorithm. This submission is for a physical medical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reasons as point 8.

Summary

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JAN 2 2 2014

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SECTION 5.

510(k) SUMMARY

for

ANKYLOS® SynCone® Abutment 5°

DENTSPLY Internationa

World Headquarters Susquehanna Commerce Cente 22 1- West Philadelphia Street Suite 60W York, PA 17401 (800) 877-0020 Fox (717) 849-4343 www.dentsply.com

-Submitter Information:

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

Contact Person:	:Helen Lewis
. " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "2 % 8ﺗTelephone Number:. "	717-487-1332
1Fax Number:	I717-849-4343

Date Prepared:

ં તે Device Name:

ANKYEOS® SynCone Abutinent 59 Proprietary Name:
December 20 .. 2013

Classification Name: Endosseous dental implant abutment 872:3630

CFR Number:
- ([
Device Class: NIJA Product Code:

ි ද Predicate Device:

ANKYLOS SynCone® Abutinents 4º and 6° cleared as part of the a ANKYLOS® Dental Implant System (K041509)
Angled ANKYLOS® Balance Base Abutments (K122268)

, 4 Description of Device:

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reatining screw design which allows for the rotation of the abutment head after attachment to the implant in order to achieve rotational alignment for all of the abutments used in the prosthetic restoration.

The DENTSPLY SynCone® Abutments are intended for use with the implants of the DENTSPLY ANKYLOS® Dental Implant System (ANKYLOS® plus, ANKYLOS® C/X implants).

In addition to the introduction of the ANKYLOS® SynCone® Abutment 5°, a modification to the indications for use statements of the currently marketed ANKYLOS® SynCone® Abutments 4° and 6° (originally cleared in premarket notification K041509, ANKYLOS Dental Implant System) is implemented as part of this premarket notification.

ഗ Indications for Use:

Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants.

Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally.

Description of Safety and Substantial Equivalence: 6.

Technological Characteristics.

The material used for the ANKYLOS® SynCone® Abutments 5°, 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. The design of the caps and the abutment cover screw corresponds to the abutments. The materials of composition for these accessory components are equivalent to existing, legally marketed accessory components and and the biocompatibility has been evidenced.

In order to assure safety of the ANKYLOS® SynCone® Abutments 5°, a failure mode, effect and criticality analysis has been performed. There were no unacceptable risks regarding the function of the ANKYLOS® SynCone® Abutments 5°.

Non-Clinical Performance Data.

Representative fatigue testing was conducted on the subject ANKYLOS® SynCone® Abutments 5° in comparison to the predicate device. The testing was conducted according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous detnal implants) and the results support substantial equivalence.

Pull force testing was conducted to verify the equivalence of the taper friction retention properties of the SynCone® Abutment 5° in comparison with those of the predicate

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abutments. The results confirmed the equivalence of the performance of the new 5° abutment with that of the predicate devices.

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® SynCone® Abutments 5° are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three abstract human figures, with their arms raised in a gesture of support or assistance. The figures are depicted in a stylized manner, with flowing lines that suggest movement and energy.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

Public Health Service

January 22, 2014

Dentsply International, Incorporated Ms. Helen Lewis Director Regulatory Affairs 221 West Philadelphia St. Suite 60 York, PA 17404 US

Re: K131644

Trade/Device Name: Ankylos syncone abutment 5(degree) Regulation Number: 21 CFR 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 23, 2013 Received: June 5, 2013

Dear Helen 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. 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

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Page 2 - Helen Lewis

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Image /page/4/Picture/6 description: The image shows the name "Kwame O. Ulmer-S" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. The background of the image appears to have some noise or texture, possibly from a scan or low-resolution image.

for

Erin I. Keith, M.S. Acting 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): દિવાદા દિવસ

Device Name: ANKYLOS® SynCone® Abutment 5°

Indications for Use:

SynCone® Abutments on osseointegrated Implants Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants

SynCone® Abutments for immediate loading

Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11 mm in length and placed interforaminally.

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)

Mary S. Runner -

5
Susan Rumen DDS, MA 2014.01.21
16:29:22-05'00'

Premarket Notification

ANK YLOS* SynCone" Abutment 50

DENTSPLY. International

000011

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.)