Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

Device Description

The Multi-Unit Abutments with Angulations 17° and 30° are available in multiple cuff heights to provide angulation correction for off-angle implant placement. The abutments are in the following sizes: 3.5mm Platform - Angled 17° - 2mmH and 3mmH, 3.5mm Platform - Angled 30° - 3mmH, 4.5mm Platform - Angled 17° - 2mmH, 3mmH, and 5mmH, 4.5mm Platform - Angled 30° - 3mmH and 5mmH. The abutment is secured to the implant with an abutment retaining screw. The abutment and abutment retaining screw are fabricated from titanium alloy. The tapered abutments facilitate multi-unit, screw-retained restoration, and are available in titanium 6AI-4V and will provide an angulation up to 30°. The abutments are provided Sterile (Gamma) and are packaged in glass vials suspended by a carrier with a screw cap and is shrink wrapped. The glass vial is sealed inside a Chevron pouch that is compatible with radiation.

AI/ML Overview

I am sorry, but the document you provided does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is primarily a 510(k) summary for a dental device (Multi-Unit Abutments) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's what the document does include:

Device Identification: Multi-Unit Abutments with Angulations 17° and 30° for Inclusive Tapered Implant System.
Predicate Device: Zimmer Dental Angled Tapered Abutment (K111853).
Device Description: Details on abutment sizes, materials (titanium alloy), and intended use.
Indications for Use: What the device is intended for (support and retention for multi-unit screw-retained restorations, with specific parallelism requirements for 30-degree and 17-degree abutments).
Substantial Equivalence Claim: The device is substantially equivalent to the predicate in intended use, indications for use, material, design, and performance.
Non-Clinical Testing:
- It states that non-clinical test data was used to support safety and effectiveness.
- Testing involved "analysis of platforms to identify worst-case test samples and their performance in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
- The conclusion of this testing was that "the device is safe and effective for its intended use and performed as well or better than the predicate device."

However, the document does NOT contain the specific details you requested, such as:

A table of acceptance criteria and reported device performance: While it mentions testing, it doesn't quantify "acceptance criteria" or provide specific performance metrics in a table format. It only states the device "performed as well or better than the predicate device."
Sample size used for the test set and data provenance: No information on how many abutments were tested or where the test data came from.
Number of experts used to establish ground truth and their qualifications: No mention of experts or ground truth establishment.
Adjudication method: Not applicable as no expert review process is described.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a physical device, not an AI or imaging system.
Standalone performance study: The non-clinical testing implicitly serves as a standalone performance evaluation against a standard and the predicate, but it's not detailed.
Type of ground truth used: Not applicable in the context of this device's testing.
Sample size for the training set: Not applicable as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

The non-clinical testing mentioned appears to be mechanical and material testing, common for implantable medical devices, rather than a clinical study or an AI algorithm validation study. The standard referenced, "FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," would outline the specific tests (e.g., fatigue strength, torque retention, biocompatibility) required for these types of devices, and presumably, the acceptance criteria would be defined within those standards. However, the summary provided here does not detail those specifics.

Summary

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K121688

Image /page/0/Picture/1 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. The logo consists of a black triangle on the left and the company name on the right. The triangle is divided into smaller triangles, creating a prism-like effect. The company name is written in bold, sans-serif font.

OCT 1 2 2012

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: Company Name 2212 Dupont Dr., Suite P. Company Address: Irvine, CA 92612 Company Phone: 949-399-1940 949-553-0924 Company FAX: Armin Zehtabchi, (949) 225-1234 Contact Person: Kathleen Dragovich, (949) 399-1940 Date Summary Prepared: October 9, 2012 DEVICE IDENTIFICATION Trade/Proprietary Name: Multi-Unit Abutments with Angulations 17° and 30° for InclusiveTapered Implant System 21 CFR Reference: 21 CFR 872.3630 21 CFR Common Name: Endosseous Dental Implant Abutment Classification: Class II

Dental NHA Panel:

C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name:

Zimmer Dental Angled Tapered Abutment (K111853)

D. DEVICE DESCRIPTION

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Image /page/1/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is in a bold, sans-serif font.

The abutment is secured to the implant with an abutment retaining screw. The abutment and abutment retaining screw are fabricated from titanium alloy. The tapered abutments facilitate multi-unit, screw-retained restoration, and are available in titanium 6AI-4V and will provide an angulation up to 30°.

K121688

The abutments are provided Sterile (Gamma) and are packaged in glass vials suspended by a carrier with a screw cap and is shrink wrapped. The glass vial is sealed inside a Chevron pouch that is compatible with radiation.

E. INDICATIONS FOR USE

F. SUBSTANTIAL EQUIVALENCE

The Multi-Unit Abutments with Angulations 17° and 30° for Tapered Implant System are substantially equivalent to the Zimmer Dental Angled Tapered Abutment (K111853). These abutments are substantially equivalent in intended use, indication for use, material, design and performance.

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. . . . .

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 and the company name on the right. The triangle is a geometric shape with sharp angles and lines. The company name is written in a bold, sans-serif font.

Comparison of Predicate Devices

Elements ofComparison	Prismatik'sMulti-Unit Abutments withAngulations 17° and 30° forTapered Implant System	Zimmer Dental AngledTapered Abutment(K111853)
Material	Titanium	Titanium
Indications	Inclusive Multi-Unit Abutmentsare prosthetic componentsdirectly connected to endosseousdental implants and intended toprovide support and retention formulti-unit screw-retainedrestorations. The 30-degreemulti-unit abutments must beused within 45 degrees ofparallelism for a splintedrestoration. The 17-degreemulti-unit abutments must beused within 32 degrees ofparallelism for a splintedrestoration.	The Angled TaperedAbutment is used for aterminal or intermediateabutment for screw-retainedmultiple-unit restorations.The 30AngledTapered Abutment must beused within 45 degree ofparallelism for asplinted restoration. The15S0Angled TaperedAbutment must be usedwithin 30 degrees ofparallelism for a splintedrestoration.
Abutment Angels	Up to 30°	Up to 30°
Platforms	3.5, 4.5mm	3.5, 4.5mm
Method ofAttachment	Internal screw threaded throughinternal hex into implant	Internal screw threadedthrough internal hex intoimplant

and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the co

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Image /page/3/Picture/0 description: The image shows a 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 triangle is filled with a gradient of black, with the darkest part at the bottom and the lightest part at the top. The company name is written in a bold, sans-serif font.

NON-CLINICAL TESTING G.

Non-clinical test data was used to support the decision of safety and effectiveness.

Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and their performance in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicated that the device is safe and effective for its intended use and performed as well or better than the predicate device.

H. CONCLUSION

The information provided in the submission demonstrates that the Multi-Unit Abutments for Angulations 17° and 30° for Inclusive Tapered Implant System are substantially equivalent to the Zimmer Dental Angled Tapered Abutment (K111853).

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

OCT 12 2012

Ms. Kathleen Dragovich Manager, Regulatory Affairs/Quality Assurance Prismatik Dentalcraft, Incorporated 2212 Dupont Drive, Suite P Irvine, California 92612

Re: K121688

Trade/Device Name: Multi-Unit Abutments with Angulations 17° and 30° for Tapered Implant System

Regulation Number: 21 CFR 872.3630

Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA

Dated: August 22, 2012

Received: August 27, 2012

Dear Ms. Dragovich:

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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Page 2 - Ms. Dragovich

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 yours,

signature

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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004-Indications for Use Statement

510 (K) Number (if known): To be determined

Multi-Unit Abutments with Angulations 17° and 30° for Device Name: Tapered Implant System

Indications for Use: Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

Prescription Use: Yes No 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 ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Suarez

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental 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.)