Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.

Device Description

Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F-136 Standard. Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos C/X in 3.5 mm, 4.5 mm, 5.5 mm, and 7.0 mm Ø sizes.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called Inclusive® Titanium Abutments. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness through clinical trials. As such, it does not detail a clinical study with acceptance criteria in the manner typically associated with AI/ML device evaluations.

Instead, the document details non-clinical testing to show equivalence. Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" in the context of this regulatory submission:

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

The document does not explicitly present "acceptance criteria" in a quantitative, measurable table as one might expect for a diagnostic AI/ML device. However, the overall acceptance criterion for this submission is substantial equivalence to predicate devices. This is demonstrated by comparing key characteristics and performance aspects.

Here's a table based on the "Comparison of Devices" section, where "performance" is reinterpreted as "similarity to predicate devices" and "acceptance" is implied by the "Same" outcome, indicating that the characteristic is equivalent or acceptable compared to the predicate.

Characteristic	Proposed Device Performance (Inclusive® Titanium Abutments)	Predicate 1 (Atlantis Abutment for Dentsply Ankylos Implant)	Predicate 2 (Inclusive Titanium Abutment Blanks)	Acceptance (Similarity)
Intended Use	Premanufactured prosthetic components directly connected to endosseous dental implants and intended for use as an aid in prosthetic rehabilitation. Compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.	Intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. Supports single and multiple tooth prosthesis, cement or screw retained. Abutment screw secures abutment.	Intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. Prosthesis can be cement retained. Abutment screw secures abutment.	Same Intended Use
Dimensions of Abutment	Cylinder Ø 9.43mm, 11.5° Taper, 2.84 Gage Point	11.5° Taper, 2.84 Gage Point	Cylinder Ø 9.43mm	Same
Abutment Screw	Detached and removable	Integrated fastening screw (mobile, not removable)	Detached and removable	Same (with Predicate 2)
Platform Compatibility	Ankylos C/X 3.5mm, 4.5mm, 5.5mm, 7.0mm	Ankylos C/X 3.5mm, 4.5mm, 5.5mm, 7.0mm	Various (Straumann Bone Level, NobelActive, Branemark)	Same (with Predicate 1)
Connection	Unigrip	Unigrip	Hexagon	Same (with Predicate 1)
Material	Ti-6AL-4V ELI (ASTM F-136)	Ti-6AL-4V ELI (ASTM F-136)	Ti-6AL-4V ELI (ASTM F-136)	Same
Design / Construction	Machined	Machined	Machined	Same
Abutment Angle	0°-30°	0°-30°	0°-20°	Same (with Predicate 1)
Implant Seat	Taper	Taper	Taper	Same
Screw Seat	Taper	Taper	Flat	Same (with Predicate 1)

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

The document describes non-clinical testing for mechanical performance, not a clinical test set with human subjects or patients.

Sample Size: Not explicitly stated as "sample size" in terms of number of patients or cases. The testing involved "finished assembled implant/abutment systems" and considered "worst case scenarios." The specific number of abutments or systems tested for Reliability Calculation and Testing, Fatigue Strength Testing, and Static Load Failure Testing is not provided in this summary.
Data Provenance: Not applicable in the context of clinical data provenance. The data comes from internal device testing performed by Prismatik Dentalcraft, Inc.

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

Not applicable. This device is an endosseous dental implant abutment, a mechanical component. Ground truth is established through engineering and material science standards and physical testing, not expert interpretation of medical images or patient outcomes.

4. Adjudication method for the test set

Not applicable. There is no "adjudication method" in the traditional sense for this type of non-clinical device testing. Performance is evaluated against engineering standards and methods.

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

Not applicable. This is not an AI/ML device or a device that impacts human reading performance.

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

Not applicable. This is not an AI/ML device. The device performs as a standalone mechanical component for dental implants.

7. The type of ground truth used

The "ground truth" for the non-clinical testing is based on:

Engineering Standards: Specifically, "FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'".
Physical Measurements and Mechanical Testing: Reliability Calculation and Testing, Fatigue Strength Testing, and Static Load Failure Testing.
Material Specifications: Adherence to "Ti-6AL-4V ELI (ASTM F-136) Standard."
Sterilization Standards: ANSI/AAMI ST79 and ISO 17665-1.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/ML device.

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

Not applicable. As there is no training set, there is no ground truth established for one.

Summary

{0}------------------------------------------------

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 stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

January 6,2015

Prismatik Dentalcraft, Incorporated Mr. Brandon Shepard Regulatory Affairs & Quality Assurance Specialist 2212 Dupont Drive, Suite P Irvine, CA 92612

Re: K141923 Trade/Device Name: Inclusive® Titanium Abutments, compatible with Dentsply Implants Ankylos® C/X Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 5, 2014 Received: December 8, 2014

Dear Mr. Shepard,

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

{1}------------------------------------------------

Page 2 - Mr. Shepard

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Susan Runno DDS, MA

Erin Keith Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the word "PRISMATIK" in bold, black letters to the right of the triangle. Below "PRISMATIK" is the text "DENTALCRAFT, INC." in a smaller, black font.

004 Indications for Use Statement

510(k) Number (if known): K141923

Device Name: Inclusive® Titanium Abutments, compatible with Dentsply Implants Ankylos® C/X

Indications for Use: Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.

Type of Use

Prescription Use: Yes > No | (Part 21 CFR 801 Subpart D)

Over-the-Counter Use: Yes | | No (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a triangular prism on the left side, with each face of the prism displaying a different color. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.

005 510(k) Summary

[As Required by 21 CFR 807.92]

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements 21 CFR 807.92.

SUBMITTER INFORMATION A.

Company Name:	PRISMATIK DENTALCRAFT, INC.
Company Address:	2212 Dupont Dr., Suite PIrvine, CA 92612
Company Phone / Fax:	(949) 225-1269 / (978) 313-0850
Contact Person:	Primary Contact:● Brandon Shepard, RA/QA Specialist(949) 225-1243
	Secondary Contact:● Marilyn Pourazar, Sr. Director RA/QA(949) 225-1269
Date Summary Prepared:	December 5, 2014

DEVICE IDENTIFICATION

Trade/Proprietary Name:	Inclusive ® Titanium Abutments,compatible with Dentsply Implants Ankylos ® C/X
Common Name:	Endosseous Dental Implant Abutment
Regulation Number:	872.3630
Product Code:	NHA
Device Class:	2
Review Panel:	Dental

{4}------------------------------------------------

C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name: Atlantis Abutment for Dentsply Ankylos Implant (K101004) Inclusive Titanium Abutment Blanks (K083192)

D. DEVICE DESCRIPTION

E. INDICATIONS FOR USE

Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.

F. SUBSTANTIAL EQUIVALENCE

Inclusive Titanium Abutments, compatible with Dentsply Implants Ankylos C/X, are substantially equivalent to the Atlantis Abutment for Dentsply Ankylos Implant (K101004) and the Inclusive Titanium Abutment Blanks (K083192). They are substantially equivalent in intended use, materials, as well as design, technological characteristics and performance.

NON-CLINICAL TESTING G.

Non-clinical test data was used to evaluate the proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.

Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and it consisted of testing finished assembled implant/abutment systems of the worst case scenario, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular shape on the left side, resembling a prism. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font size.

In addition, sterilization validation information and recommended sterilization method based on ANSI/AAMI ST79 and ISO 17665-1 is provided in the Information for Use.

The testing performed demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.

CONCLUSION H.

The results of the nonclinical testing performed, demonstrate that Inclusive Titanium Abutments, compatible with Dentsply Implants Ankylos C/X are as safe, as effective, and perform as well as the predicate devices. Therefore the proposed device is substantially equivalent with the predicate devices cleared for the same intended use.

(See Comparison Table Below)

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the word "PRISMATIK" in bold, black letters to the right of the triangle. Below "PRISMATIK" is the text "DENTALCRAFT, INC." in a smaller, non-bold font.

PREDICATES		PROPOSED
Atlantis Abutment forDentsply AnkylosImplant	Inclusive TitaniumAbutment Blanks	Inclusive TitaniumAbutments,compatible withDentsply ImplantsAnkylos C/X	Similarities /Differencesof Devices
Manufacturer	Astra Tech	Prismatik	Prismatik	-
510(k) No.	K101004	K083192	K141923	-
Indicationsfor Use	The Atlantis Abutmentis intended for use withan endosseous implantto support a prostheticdevice in a partially orcompletely edentulouspatient. It is intended foruse to support single andmultiple toothprosthesis, in themandible or maxilla.The prosthesis can becement or screw retainedto the abutment. Theabutment screw isintended to secure theabutment to theendosseous implant.	The InclusiveTitanium AbutmentBlank is intended to beused in conjunctionwith endosseousimplants in themaxillary and/ormandibular arch toprovide support forcrowns, bridges oroverdentureprostheses. Theprosthesis can becement retained to theabutment. Theabutment screw isintended to secure theabutment to theendosseous implant.	Inclusive TitaniumAbutments arepremanufacturedprostheticcomponents directlyconnected toendosseous dentalimplant and areintended for use asan aid in prostheticrehabilitation.	SameIntendedUse
Dimensions ofAbutment	11.5° Taper,2.84 Gage Point	Cylinder Ø 9.43mm	Cylinder Ø 9.43mm11.5° Taper,2.84 Gage Point	Same
AbutmentScrew	Integrated fasteningscrew (mobile, notremovable)	Detached andremovable	Detached andremovable	Same
PlatformCompatibility	Ankylos C/X3.5mm, 4.5mm,5.5mm, 7.0mm	Various (StraumannBone Level,NobelActive,Branemark)	Ankylos C/X3.5mm, 4.5mm,5.5mm, 7.0mm	Same
Connection	Unigrip	Hexagon	Unigrip	Same
Material	Ti-6AL-4V ELI(ASTM F-136)	Ti-6AL-4V ELI(ASTM F-136)	Ti-6AL-4V ELI(ASTM F-136)	Same
Design /Construction	Machined	Machined	Machined	Same
AbutmentAngle	0°-30°	0°-20°	0°-30°	Same
Implant Seat	Taper	Taper	Taper	Same
Screw Seat	Taper	Flat	Taper	Same

Comparison of Devices

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.)