Hahn Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

Device Description

The Hahn Tapered Implant System consists of dental implants, abutments, screws, and surgical instruments. They are manufactured from Titanium alloy, grade 23. The implant is designed with an internal hex connection and a tapered body to replace one or more missing teeth. The surface is blasted with Hydroxyl Apatite and acid etched to facilitate osseointegration. The Implants are design with two (2) platform connection geometries; they are available in the following diameters: 3.0mm, 3.5mm, 4. 3mm, 5.0mm, and 7. 0mm diameter is available in the following lengths: 8mm, 10mm, 11.5mm, 13mm, and 16mm. The dental implants are provided sterile (gamma radiation).

AI/ML Overview

The document describes the Hahn Tapered Implant System, a dental implant system from Prismatik Dentalcraft, Inc. The submission is a 510(k) premarket notification, which means the company is demonstrating that their device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating this substantial equivalence through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly that the new device performs at least as well as the predicate device in specified non-clinical tests. The reported performance is that the device met these criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Performance demonstrated to be "as safe, as effective, and performs as well as the predicate device(s)" in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"	"The testing performed established that the predicate device is as safe, as effective, and performs as well as the predicate device(s)." "All differences between the predicate and proposed devices have been evaluated per the testing described in section F (non-clinical testing) and the proposed device has performed as well as the predicate; the devices are substantially equivalent."
Reliability Calculation (as per FDA Guidance)	Performed; device found to be substantially equivalent to predicate.
Fatigue Testing of finished assembled implant/abutment systems (as per FDA Guidance)	Performed; device found to be substantially equivalent to predicate.
Static Load Failure Testing of finished assembled implant/abutment systems (as per FDA Guidance)	Performed; device found to be substantially equivalent to predicate.

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

The document explicitly states that non-clinical testing was used.

Sample Size: The document does not specify the exact number of samples used for reliability calculation, fatigue testing, or static load failure testing. It generally states that "Non-clinical test data was used."
Data Provenance: The data is from non-clinical (laboratory/mechanical) testing, not human patient data. Therefore, concepts like "country of origin" or "retrospective/prospective" don't apply in the traditional sense for clinical studies. It would be generated in a lab setting by the manufacturer or a contracted lab.

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

This information is not applicable as the study described is a non-clinical, mechanical performance study, not one requiring expert review of data like medical images or clinical outcomes. Ground truth for mechanical tests usually comes from standardized test methods and established engineering principles.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is a non-clinical, mechanical performance study, not one requiring adjudication of human-interpreted results.

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, an MRMC comparative effectiveness study was not done. This submission is for a medical device (dental implant system), not an AI/software device that assists human readers.

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

No, a standalone (algorithm only) performance study was not done. This submission is for a physical medical device.

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

The "ground truth" for this non-clinical study would be the physical and mechanical properties and performance characteristics of the dental implants as measured by standardized engineering test methods (e.g., measuring load to failure, fatigue life). The acceptance criteria are based on performing at least as well as the predicate device in these objective, measurable parameters, guided by FDA special controls guidance.

8. The Sample Size for the Training Set

This information is not applicable. This is a non-clinical (mechanical) study of a physical device, not an AI/machine learning model that requires a training set.

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

This information is not applicable for the same reasons as #8.

Summary

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

April 2, 2015

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

Re: K143353 Trade/Device Name: Hahn Tapered Implant System

Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 2, 2015 Received: March 3, 2015

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply

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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. Division 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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Image /page/2/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with different colors. The text "PRISMATIK DENTALCRAFT, INC." is on the right side of the triangle.

S	A F
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Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known)	K143353
Device Name	Hahn Tapered Implant System
Indications for Use (Describe)	Hahn Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.
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)

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Image /page/3/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 blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

005 510(k) Summary

[As Required by 21 CFR 807.92]

This 510(k) summary of substantial equivalence 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, (949) 225-1243
	Secondary Contact:Marilyn Pourazar, (949) 225-1269
Date Summary Prepared:	March 2, 2015
DEVICE IDENTIFICATION
Trade/Proprietary Name:	Hahn Tapered Implant System.
Common Name:	Endosseous Dental Implant System
Regulation Number:	872.3640
Product Code:	DZE
Device Class:	2
Review Panel:	Dental

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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including pink, blue, yellow, and green. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue.

IDENTIFICATION OF PREDICATE DEVICE C.

Trade/Proprietary Name: Inclusive Tapered Implant System (K121406)

DEVICE DESCRIPTION D.

E. INDICATIONS FOR USE

F. NON-CLINICAL TESTING

Non-clinical test data was used to evaluate the device's performance, 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.

The testing performed established that the predicate device is as safe, as effective, and performs as well as the predicate device(s).

SUBSTANTIAL EQUIVALENCE STATEMENT G.

The proposed device is substantially equivalent with the predicate (K121406) in regards to intended use, materials, design, and performance. In conclusion, the testing and evaluations conducted demonstrate that Hahn Tapered Implant System performs as well as the predicate device.

(See Comparison Tables below).

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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a prism-like design, featuring a spectrum of colors. To the right of the triangle are the words "PRISMATIK" and "DENTALCRAFT, INC." stacked on top of each other. The text is in a blue sans-serif font.

Comparison of Predicate and Proposed Devices

Attributes	Predicate Device	Proposed Device	Similarities / Differences
Device Name	Inclusive Tapered ImplantSystem (K121406)	Hahn Tapered ImplantSystem
Indications for Use	Inclusive Tapered Implantsare indicated for use inmaxillary and mandibularpartially or fully edentulouscases, to support single,multiple-unit, andoverdenture restorations.The implants are to be usedfor immediate loading onlyin the presence of primarystability and appropriateocclusal loading.	Hahn Implants are indicatedfor use in maxillary andmandibular partially or fullyedentulous cases, to supportsingle, multiple-unit, andoverdenture restorations. Theimplants are to be used forimmediate loading only in thepresence of primary stabilityand appropriate occlusalloading.	Same
Surface	Blasted with HydroxylApatite	Blasted with HydroxylApatite	Same
Connection	Internal Hex	Internal Hex	Same
Design	Threaded root-form implant	Threaded root-form implant	Same
Implant BodyGeometry	Screw Type	Screw Type	Same
Diameters (mm)	3.7, 4.7, 5.2	3.0, 3.5, 4.3, 5.0, and 7.0	AdditionalSizes
Lengths (mm)	8, 10, 11.5, 13, and 16	8, 10, 11.5, 13, and 16	Same
Sterility	Packaged Sterile	Packaged Sterile	Same
Material	Titanium Alloy, Grade 23	Titanium Alloy, Grade 23	Same
Abutment Angle	0°-20°	0°-30°	IncreasedAngulationRange
Abutment Seat	Sits on a taper	Sits on a taper	Same
Screw Seat	Sits on a flat	Sits on a taper	Tapered vs.Flat
Anatomical Site	Oral Cavity	Oral Cavity	Same
Construction	Machined	Machined	Same
Conclusion	All differences between the predicate and proposed devices have been evaluatedper the testing described in section F (non-clinical testing) and the proposeddevice has performed as well as the predicate; the devices are substantiallyequivalent.

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.