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

Device Description

Inclusive® Titanium Abutments for Hiossen HG Implant System are made of Titanium Alloy (Ti-6Al-4V) and are premanufactured prosthetic components connected directly to the endosseous dental implant and intended as an aid in prosthetic rehabilitation. They are compatible with Hiossen HG Implant System (Mini and Standard). The anti-rotational feature for Inclusive® Titanium Abutment is a hexagon. The numerical value which defines the across flats of the hexagon is 2.10 mm for the Mini, and 2.50 mm for Standard. Both have a tolerance range of ±0.05 mm.

AI/ML Overview

This is a 510(k) summary for a dental device, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria based on this document.

Here's the information regarding the non-clinical testing and acceptance criteria for the Inclusive® Titanium Abutments compatible with Hiossen HG Implant System:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and then "reported device performance." Instead, it states that non-clinical testing was performed based on FDA Guidance and relevant ISO/ASTM standards to demonstrate "implant to abutment compatibility" and "substantial equivalence" to predicate devices. The "reported device performance" is a general statement that the testing results and evaluations demonstrate this compatibility.

However, we can infer the acceptance criteria from the mentioned tests and standards:

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance with ASTM F136-12a (Material properties)	Inclusive® Titanium Abutments are manufactured from biocompatible titanium grade 23 (Ti-6AL-4V ELI) and it meets ASTM F-136 Standard.
Compliance with AAMI/ANSI/ISO 10993-1:2009 (Biocompatibility)	Biocompatibility was established by identifying several of Prismatik's own predicate devices (K073217, K100993, K121391) with identical materials, same manufacturing process, and same type/duration of patient contact. (In lieu of performing new testing).
Compliance with ISO14801:2007 (Dynamic fatigue test)	Fatigue Testing of finished assembled implant/abutment systems was performed in accordance with this standard. The testing results and evaluations demonstrate implant to abutment compatibility and support substantial equivalence. (Specific numerical results are not provided in this summary).
Static Load Failure Testing (No specific standard mentioned)	Static Load Failure Testing of finished assembled implant/abutment systems was performed. The testing results and evaluations demonstrate implant to abutment compatibility and support substantial equivalence. (Specific numerical results are not provided in this summary).
Compatibility with Hiossen HG Implant System	The testing performed demonstrated implant to abutment compatibility and supports the substantial equivalence of the subject device to the identified predicate. (Specifically for the Mini and Standard abutments with 2.1mm and 2.5mm across flats of hex, respectively, as shown in the comparison table).
Sterilization Validation (AAMI/ANSI 17665, ISO 17665-1/2, ST79)	Sterilization validation information and a recommended sterilization method based on ANSI/AAMI ST79 and ISO 17665-1 is provided in the Information for Use. This indicates that the device can be effectively sterilized according to recognized standards. (No specific performance data on sterilization effectiveness is presented in this summary).

Study Details (Not applicable for AI/ML, but details for this medical device are provided):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the exact sample sizes (e.g., number of abutments tested) for the fatigue and static load failure tests. It refers to "finished assembled implant/abutment systems." The data provenance is not explicitly mentioned, but it would be from internal testing conducted by Prismatik Dentalcraft, Inc. (Irvine, CA, USA). These are non-clinical bench tests (prospective under controlled lab conditions).
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):
Not applicable, as this is a physical medical device and its performance is evaluated through engineering bench tests, not expert interpretation of data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Device performance is determined by meeting engineering specifications and test outcomes, not by expert adjudication.
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, as this is a physical medical device, not an AI/ML system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on established engineering principles, material science, and performance standards as outlined in ASTM F136-12a, ISO14801:2007, and the FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." For biocompatibility, it's based on prior successful predicate devices with identical materials and processes.
The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI/ML system.
How the ground truth for the training set was established:
Not applicable, as this is a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol, indicating the department's name and national affiliation.

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

October 7, 2015

PRISMATIK DENTALCRAFT, INC. Mr. Armin Zehtabchi Senior RA 2212 Dupont Dr., Suite P Irvine, California 92612

Re: K151375

Trade/Device Name: Inclusive Titanium Abutments compatible with: Hiossen HG Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 21, 2015 Received: May 22, 2015

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 devicerelated 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 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, Tina Kiang -S

for 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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

510(k) Number (if known)	TBD
Device Name	Inclusive® Titanium Abutments compatible with: Hiossen HG Implant System
Indications for Use (Describe)	Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC."

006_510 (K) Summary-807.92(c)

This 510 (k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92.

SUBMITTER INFORMATION A.

Company Name:	Prismatik Dentalcraft, Inc.
Company Address:	2212 Dupont Dr., Suite P,Irvine, CA 92612
Company Phone:	949-225-1269
Company FAX:	949-553-0924
Facility Registration Number:	3005477956
Primary Contact Person:	Armin Zehtabchi, (949) 225-1234Senior RA Specialist
Secondary Contact Person	Marilyn Pourazar, (949) 225-1269Senior Director, RA/QA
Date Summary Prepared:	September 25, 2015
DEVICE IDENTIFICATION
Trade/Proprietary Name:	Inclusive® Titanium Abutments compatiblewith: Hiossen HG Implant System
21 CFR Reference:	21 CFR 872.3630
21 CFR Common Name:	Abutment, implant, dental, endosseous
Classification:	Class II, NHA
Panel:	Dental

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Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with a color gradient from blue to pink. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC." in a sans-serif font. The text is a dark teal color.

C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name:

Predicate Device: Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants=510(k)-K100993

Reference Device: HS/HG Prosthetic System-510(k)K100245

D. PROPOSED DEVICE DESCRIPTION

The anti-rotational feature for Inclusive® Titanium Abutment is a hexagon. The numerical value which defines the across flats of the hexagon is 2.10 mm for the Mini, and 2.50 mm for Standard. Both have a tolerance range of ±0.05 mm.

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 to prosthetic rehabilitation.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE F.

Inclusive® Titanium Abutments compatible with: Hiossen HG Implant System is substantially equivalent to the Predicate Device, Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants-510(k)-K100993, and the Reference Device, HS/HG Prosthetic System-510(k)-K100245 identified in Section C above. They are substantially equivalent in intended use, materials, design and performance.

(See Comparison Tables below)

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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

Attribute	Reference Device (1)	Predicate Device (1)	Proposed Device	SimilaritiesandDifferencesof Devices
	HS/HG ProstheticSystem (K100245)Osstem ImplantCo. Ltd(Subsidiary ofHiossen Inc)	Inclusive® Titanium Abutmentfor Astra Tech OsseoSpeed™Implants (K100993)Prismatik Dentalcraft, Inc.	Inclusive TitaniumAbutments compatiblewith: Hiossen HG ImplantSystemPrismatik Dentalcraft, Inc.
Dimensions ofAbutment	Mini - 2.1 AcrossFlats of HexStandard - 2.5Across Flats ofHex	3.5/4.0 - 2.1 Across Flats of Hex4.5/5.0 - 2.5 Across Flats of Hex	Mini - 2.1 Across Flats ofHexStandard - 2.5 Across Flats ofHex	Same
Dimensions ofAbutment Screw	Mini - Length -10.7mm, ScrewHead - 2.2mmStandard - Length -8.85mm, ScrewHead - 2.5mm	3.5/4.0 - Length 8.25mm, ScrewHead 2.33mm 4.5/5.0 - Length -10.3mm, Screw Head 2.33mm	Mini - Length - 10.3mm,Screw Head - 2.2mmStandard - Length - 8.35mm,Screw Head - 2.3mm	Differentscrewsdimensions
Indications forUse	HS/HG ProstheticSystem is intendedfor use with thedental implant toprovide support forprostheticrestorations such ascrowns, bridges, oroverdentures.	The Inclusive TitaniumAbutments for AstraOsseoSpeed™ Implants arepremanufacturedprosthetic components directlyconnected to endlosseous dentalimplants and are intendedfor use as an aid in prostheticrehabilitation. They arecompatible with the Astra TechOsseoSpeed™ 3.0, 3.5, 4.0, 4.5,5.0 implants.	Inclusive TitaniumAbutments arepremanufactured prostheticcomponents directlyconnected to endosseousdental implant and areintended for use as an aid inprosthetic rehabilitation.	Similarintended usefor theadditional usewith Hiossenmini2.1 andStandard 2.5
PlatformDiameterCompatibility	Hiossen HG Mini(2.1 Across Flatsof Hex andStandard (2.5Across Flats ofHex	Astra Tech OsseoSpeed™Implants 3.5/4.04.5/5.0	Hiossen HGMini - 2.1 Across Flats ofHexStandard - 2.5 Across Flatsof Hex	Same asReferencepredicate
Connection	Hexagonal	Hexagonal	Hexagonal	Same
Material	Titanium alloy(Ti-6AL-4V)	Titanium alloy(Ti-6AL-4V)	Titanium alloy(Ti-6AL-4V)	Same
Design /Construction	Machined	Machined	Machined	Same
Attribute	Reference Device (1)	Predicate Device (1)	Proposed Device	SimilaritiesandDifferencesof Devices
	HS/HG ProstheticSystem(K100245)Osstem ImplantCo. Ltd(Subsidiary ofHiossen Inc)	Inclusive® Titanium Abutmentfor Astra Tech OsseoSpeed™Implants (K100993)Prismatik Dentalcraft, Inc.	Inclusive TitaniumAbutments compatiblewith: Hiossen HG ImplantSystemPrismatik Dentalcraft, Inc.
Anatomical Site /Placement	Oral Cavity /Tissue Level	Oral Cavity / Tissue Level	Oral Cavity / Tissue Level	Same
Abutment Angle	0-30°	0-20°	0-30°	Similar

Table 1 – Comparison between Predicate and Proposed Device

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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors radiating from the center. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.

G. NON-CLINICAL TESTING (PERFORMANCE DATA)

Non-clinical test data was used to evaluate the device's equivalence, and determine substantial equivalence with predicate devices.

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 Reliability Calculation, Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems, and the testing results and evaluations demonstrate the implant to abutment compatibility between the proposed and predicate/reference devices. The detailed discussion and the testing procedure can be found in Section 018 (Performance Testing-Bench). The applicable standards that are used in this submission are listed below:

	Applicable Standards
ASTM F136-12a	Standard for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloyfor Surgical Implant Applications
AAMI/ANSI/ISO 10993-1:2009	Biological Evaluation of Medical Devices - Part1: Evaluation and Testing within a RiskManagement Process (Biocompatibility)
ISO14801:2007	Dentistry - Implants - Dynamic fatigue test forendosseous dental implants
AAMI/ANSI 17665👎2006	Sterilization of health care products - Moist Heat- Part 1: Requirements for the development,validation and routine control of a sterilizationprocess for medical devices
AAMI/ANSI/ISO 17665-2:2009	Sterilization of Health Care Products - Radiation- Part 2: Guidance of on the application of ISO17665-1
ANSI/AAMI ST79:2010 &A1:2010 &A2:2011 & A3:2012 & A4:2013	(Consolidated Text) Comprehensive guide tosteam sterilization and sterility assurance inhealth care facilities

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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including blue, pink, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font.

Inclusive® Titanium Abutments are manufactured from biocompatible titanium grade 23 (Ti-6AL-4V ELI) and it meets ASTM F-136 Standard. In accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", in lieu of performing biocompatibility testing per ISO 10993-1 for the subject device, we have identified several of Prismatik own predicate devices with identical materials, same manufacturing process, and same type/duration of patient contact:

K073217, Inclusive® Abutment for Zimmer, 3i and Nobel Biocare Implants -
K100993, Inclusive® Titanium Abutments for Astra OsseoSpeed Implants -
K121391, Inclusive® Titanium Abutment for Camlog Screw-Line Implants -

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

CONCLUSION FROM THE NON-CLINICAL TESTING (PERFORMANCE DATA) H.

The proposed device, the Inclusive® Titanium Abutments compatible with: Hiossen HG Implant System have the same performance specifications, fundamental scientific technology and intended use as that of the Predicate Device, Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants-510(k)-K100993, and the Reference Device, HS/HG Prosthetic System-510(k)-K100245 identified in Section C above. The testing performed demonstrated implant to abutment compatibility and supports the substantial equivalence of the subject device to the identified predicate.

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.)