K Number

Device Name

Hahn Tapered Implant System

Manufacturer

PRISMATIK DENTALCRAFT, INC.

Date Cleared

2015-04-02

(129 days)

Product Code

DZE

Regulation Number

872.3640

Intended Use

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).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K121406

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental implant system and does not mention any software, algorithms, or capabilities that would suggest the use of AI or ML. The performance studies focus on mechanical testing, not algorithmic performance.

Therapeutic

Yes
The device, a dental implant system, directly replaces missing teeth to support restorations, which is a therapeutic intervention.

Diagnostic

Explanation: The device is described as a dental implant system used for replacing missing teeth, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to identify or analyze a condition.

SaMD (Software as a Medical Device)

The device description explicitly lists physical components such as dental implants, abutments, screws, and surgical instruments made of Titanium alloy. This indicates a hardware-based medical device, not a software-only one.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Description and Intended Use: The provided text clearly describes a dental implant system used to replace missing teeth. It is surgically implanted into the bone and supports dental restorations. This is a device used in vivo (within the body), not in vitro (in a test tube or lab setting).
Lack of Diagnostic Function: The device's purpose is structural and restorative, not to diagnose a condition or provide information about a patient's health through testing of samples.

Therefore, based on the provided information, the Hahn Implants are not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DZE

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral Cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121406

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

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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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)

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

FOR FDA USE ONLY

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FORM FDA 3881 (1/14)

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PSC Publishing Services (301) 443-6740 EF

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 P
Irvine, 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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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.

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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Comparison of Predicate and Proposed Devices

Attributes	Predicate Device	Proposed Device	Similarities / Differences
Device Name	Inclusive Tapered Implant
System (K121406)	Hahn Tapered Implant
System
Indications for Use	Inclusive Tapered 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.	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.	Same
Surface	Blasted with Hydroxyl
Apatite	Blasted with Hydroxyl
Apatite	Same
Connection	Internal Hex	Internal Hex	Same
Design	Threaded root-form implant	Threaded root-form implant	Same
Implant Body
Geometry	Screw Type	Screw Type	Same
Diameters (mm)	3.7, 4.7, 5.2	3.0, 3.5, 4.3, 5.0, and 7.0	Additional
Sizes
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°	Increased
Angulation
Range
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 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.