The Inclusive Titanium Abutments for Camlog Screw-Line Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the CAMLOG Screw-Line Implants in 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.

Device Description

The Inclusive® Titanium Abutments for Camlog Screw-Line Implants are endosseous implant abutments which are placed in to the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. These abutments are made of titanium grade Ti-6AL-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. These abutments are compatible with the CAMLOG Screw-Line Implants as follows: 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.

AI/ML Overview

This document describes the non-clinical testing for the Inclusive Titanium Abutments for Camlog Screw-Line Implants. It focuses on demonstrating substantial equivalence to a predicate device through mechanical performance testing rather than clinical study. Consequently, information typically associated with clinical studies, such as multi-reader multi-case studies, ground truth establishment for clinical endpoints, or human reader performance, is not applicable or provided.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material	Ti -6AL-4V ELI
Indications	Premanufactured prosthetic components directly connected to endosseous dental implants, intended for use as an aid in prosthetic rehabilitation. Compatible with CAMLOG Screw-Line Implants (3.3mm, 3.8mm, 4.3mm, 5.0mm, 6.0mm diameters).
Platform Diameters (mm)	3.3mm, 3.8mm, 4.3mm, 5.0mm, 6.0mm.
Design	Implant/Abutment assembly with abutment screw. Abutment prosthetic connection to implant is 3 internal radial features.
Performance (Mechanical Compatibility)	Fatigue testing in accordance with ISO 14971 - Dynamic fatigue test for endosseous dental implants conducted to validate mechanical compatibility with Camlog implants. All testing conducted met the acceptance criteria and evaluated the worst-case scenario. Performance testing data indicated compatibility between implant/abutment.
Sterilization Validation	Sterilization validation/instructions by following the ANSI-AAMI ST79-2006: Comprehensive guide to steam sterilization and sterility assurance in health care facilities is provided in the Information for Use (IFU).

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

Test Set Sample Size: The document does not specify a numerical sample size for the mechanical performance testing. It states that "All testing conducted met the acceptance criteria and evaluated the worst-case scenario," implying sufficient testing was performed to cover relevant configurations and conditions.
Data Provenance: The data provenance is from laboratory mechanical testing. This is a non-clinical study, not directly tied to a specific country of origin for patient data. It is inherently retrospective as the testing has already been completed.

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

This question is not applicable as the study is a non-clinical mechanical performance study rather than a study with human subject data requiring expert ground truth for clinical outcomes. The "ground truth" here is the adherence to established engineering standards (ISO 14801, ISO 14971, ANSI-AAMI ST79-2006).

4. Adjudication Method for the Test Set

This question is not applicable as the study is a non-clinical mechanical performance study. Adjudication methods are typically employed in clinical trials to resolve discrepancies in expert assessments of clinical endpoints.

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 question is not applicable. The device is a physical dental implant component, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study involving human readers with or without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical dental implant component, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is defined by established engineering and medical device standards:
- Mechanical Performance: ISO 14801: 2007 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
- Mechanical Compatibility: ISO 14971 - Dynamic fatigue test for endosseous dental implants.
- Sterilization Validation: ANSI-AAMI ST79-2006: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
- Design Conformance: Conformance to design input and parameters determined by reverse engineering of existing, approved devices.

8. The Sample Size for the Training Set

This question is not applicable as the study is a non-clinical mechanical performance study and does not involve AI or machine learning that requires a "training set" of data.

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

This question is not applicable for the reasons stated in point 8.

Summary

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K121391

510 (k) Summary

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

SUBMITTER INFORMATION A.

Prismatik Dentalcraft, Inc. Company Name: 2212 Dupont Dr., Suite IJK, Company Address: Irvine, CA 92612 (949) 225-1269 Company Phone: 949-553-0924 Company FAX: Armin Zehtabchi, (949) 225-1234 Primary Contact Person: Marilyn Pourazar, (949) 225-1269 Secondary Contact Person December 5, 2012 Date Summary Prepared: DEVICE IDENTIFICATION Inclusive Titanium Abutments for Camlog Trade/Proprietary Name: Screw-Line Implants 21 CFR 872.3630 21 CFR Reference: Endosseous Dental Implant Abutment 21 CFR Common Name: Class II Classification: NHA Product Code: Dental Panel:

IDENTIFICATION OF PREDICATE DEVICE C.

Trade/Proprietary Name:

CAMLOG Implant System Abutments (K073553)

DEVICE DESCRIPTION

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KI 21391

Image /page/1/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC.", in blue text.

for cemented restorations. These abutments are made of titanium grade Ti-6AL-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw.

These abutments are compatible with the CAMLOG Screw-Line Implants as follows: 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.

INDICATIONS FOR USE D.

The Inclusive® Titanium Abutments for Camlog Screw-Line Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the CAMLOG Screw-Line Implants in 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.

SUBSTANTIAL EQUIVALENCE

The Inclusive® Titanium Abutments for Camlog Screw-Line Implants are substantially equivalent to the CAMLOG Implant System Abutments (K073553). These abutments are substantially equivalent in intended use, indication for use, material, design and performance.

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K121391

. :

・ . :

Image /page/2/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left side and the company name on the right side. The company name is written in a bold, sans-serif font. The logo is simple and modern.

. .

Elements of	Prismatik's	CAMLOG Implant
Comparison	Inclusive Titanium Abutments	System Abutments
	for Camlog Screw-Line	(K073553)
	Implants
Material	Ti -6AL-4V ELI	Ti -6AL-4V
Indications	The Inclusive® TitaniumAbutments for CamlogScrew-Line Implants arepremanufactured prostheticcomponents directlyconnected to endosseousdental implants andare intended for use as anaid in prosthetic rehabilitation.They are compatible with theCAMLOG Screw-LineImplants.	CAMLOG ImplantSystem Abutments areintended to be used tofabricate crowns andbridges in conjunctionwith CAMLOG dentalimplants to supportprostheses in themaxillary and/ormandibular arch.
PlatformDiameters(mm)	3.3mm, 3.8mm, 4.3mm, 5.0mm,6.0mm.	3.3mm, 3.8mm, 4.3mm,5.0mm, 6.0mm.
Design	Implant/Abutment assembly withabutment screw. Abutmentprosthetic connection to implantis 3 internal radial features.	Implant/Abutmentassembly with abutmentscrew. Abutmentprosthetic connection toimplant is 3 internalradial features.
Performance	Fatigue testing in accordancewith ISO 14971 - Dynamicfatigue test for endosseous dentalimplants conducted to validatemechanical compatibility withCamlog implants.	Substantially equivalentin indications and designto predicated devicesdetermined to besubstantially equivalentto pre-amendmentdevices.

Comparison of Predicate Devices

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E. NON-CLINICAL TESTING

Non-clinical test data was used to support the substantial equivalency.

The parameters of the abutment features that interface with the implant systems were determined by reverse engineering. The functionality of the abutments as well as their conformance to design input was further determined by laboratory mechanical testing. The following FDA's Guidance Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments was used for the purpose of Implant to Abutment Compatibility. Static and fatigue tests were performed by following the ISO 14801: 2007- Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. All testing conducted met the acceptance criteria and evaluated the worst case scenario. Performance testing data indicated the compatibility between implant/abutment. In addition, the sterilization validation/instructions by following the ANSI-AAMI ST79-2006: Comprehensive guide to steam sterilization and sterility assurance in health care facilities is provided in the Information for Use (IFU). Furthermore, the Prismatik's predicate device (K100993) is made of Titanium alloy.

F. CONCLUSION

The information provided in the submission demonstrates that the Inclusive® Titanium Abutments for Camlog Screw-Line Implants are substantially equivalent to the Camlog Implant System Abutments.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

December 10, 2012

Mr. Armin Zehtabchi Senior Regulatory Affairs / Quality Assurance Coordinator Prismatik Dentalcraft, Incorporated 2212 Dupont Drive, Suite P IRVINE CA 92612

Re: K121391

Trade/Device Name: Inclusive Titanium Abutment for Camlog Screw-Line Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 5, 2012 Received: December 6, 2012

Dear Mr. Zehtabchi:

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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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/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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthem Lo m

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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INDICATIONS FOR USE STATEMENT

510(K) Number: K121391

Device Name:

Inclusive Titanium Abutment for Camlog Screw-Line Implants

Indications for Use:

The Inclusive Titanium Abutments for Camlog Screw-Line Implants are premanufactured The inclusive Thamum Abauments for Cannon and implants and are intended for use prosthence components ancelly of the are compatible with the Camlog Screw-Line Implants in 3.3mm, 3.8mm, 4.3mm, 5.0mm and 6.0mm diameters.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 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)

2012.12.10 Susan Runner DDS, MA 12:18:21 -05'00'

(Division Sign-Off) . (Division Signoli)
Division of Anesthesiology, General Hospital Division of Antonioental 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.)