K Number
K141211
Device Name
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
Date Cleared
2014-10-22

(166 days)

Product Code
Regulation Number
872.3630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive Titanium Abutments are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.
Device Description
Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. Abutments are to be provided straight and are not intended for any angulation correction.
More Information

Not Found

No
The device description and performance studies focus on the mechanical properties and compatibility of a physical dental abutment, with no mention of software, algorithms, or data processing that would indicate AI/ML use.

No.
The device is a prosthetic component designed to support dental restorations, not to treat or cure a disease or condition.

No

The device is an Inclusive Titanium Abutment, a prosthetic component for dental implants. Its intended use is for prosthetic rehabilitation and it provides support for a prosthetic restoration. It performs a structural and supportive function, not a diagnostic one.

No

The device description explicitly states that the device is made of titanium alloy and is a physical component (abutment and screw) placed into a dental implant. This indicates it is a hardware device, not software only.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Device Description: The description clearly states that the Inclusive Titanium Abutments are "premanufactured prosthetic components directly connected to endosseous dental implants" and are used "as an aid in prosthetic rehabilitation." They are physical components placed within the mouth to support dental restorations.
  • Intended Use: The intended use is for prosthetic rehabilitation in the mouth, not for testing biological samples.
  • Lack of IVD Characteristics: The description does not mention any testing of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.

The device is a dental prosthetic component, not a diagnostic tool.

N/A

Intended Use / Indications for Use

Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive Titanium Abutments are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.

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

NHA

Device Description

Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. Abutments are to be provided straight and are not intended for any angulation correction.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.

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 testing finished assembled implant/abutment systems of the worst case scenario, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.

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

The testing performed demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.

The results of the nonclinical testing performed, demonstrate that Inclusive Titanium Abutments compatible with Straumann Standard Plus Tissue Level Implants perform as well as the predicate devices. Therefore the proposed device is substantially equivalent with the predicate devices cleared for the same intended use.

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.

K033243, K083192

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

§ 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.)

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, all facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

OCtober 22, 2014

Prismatik Dentalcraft, Incorporated Mr. Armin Zehtabchi Senior Regulatory Affairs 2212 Dupont Drive, Suite P Irvine, CA 92612

Re: K141211

Trade/Device Name: Inclusive® Titanium Abutments, compatible with Straumann® Standard Plus Tissue Level Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 19, 2014 Received: September 22, 2014

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.

1

Page 2 - Mr. Zehtabchi

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

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

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Image /page/2/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.

004 Indications for Use Statement

510(k) Number (if known): K141211

Device Name:Inclusive ® Titanium Abutments, compatible with Straumann ® Standard Plus Tissue Level Implants
-------------------------------------------------------------------------------------------------------------------------------------

| Indications for Use: | Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive Titanium Abutments are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. |

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Type of Use

Prescription Use: Yes > 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 A SEPARATE PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.

005 510(k) Summary

[As Required by 21 CFR 807.92]

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

SUBMITTER INFORMATION A.

B.

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
Primary Contact Person:Armin Zehtabchi, (949) 225-1234
Senior RA
Secondary Contact Person:Marilyn Pourazar, (949) 225-1269
Sr. Director, RA/QA
Date Summary Prepared:October 21, 2014
DEVICE IDENTIFICATION
Trade/Proprietary Name:Inclusive® Titanium Abutments, compatible with
Straumann® Standard Plus Tissue Level Implants
Common Name:Endosseous Dental Implant Abutment
Regulation Number:872.3630
Product Code:NHA
Device Class:II
Review Panel:Dental

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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the word "PRISMATIK" in bold, black letters on the right side. Below the word "PRISMATIK" is the phrase "DENTALCRAFT, INC." in a smaller, black font. The logo is simple and modern, and the use of color in the triangle makes it visually appealing.

C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name: ITI synOcta Meso Abutments (K033243) Inclusive Titanium Abutment Blanks (K083192)

D. DEVICE DESCRIPTION

Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. Abutments are to be provided straight and are not intended for any angulation correction.

| | Inclusive Titanium Abutments, compatible with
Straumann Standard Plus Tissue Level Implants | |
|------------------------|------------------------------------------------------------------------------------------------|--|
| Platform Compatibility | Straumann synOcta | |
| Platform Diameter (mm) | RN 4.8 mm, WN 6.5 mm | |
| Dimension of Abutment | Blank Abutment: 13.30 mm long, 9.44 mm diameter | |
| Dimensions of Screw | 8 mm long, M2.0 thread | |
| Connection | Octagonal | |
| Material | Titanium Alloy (ASTM F136) | |
| Design / Construction | Machined | |
| Surface Treatment | None | |
| Abutment Angle | Straight, 0° | |
| Implant Seat | Sits on a Taper | |
| Screw Seat | Sits on a Taper | |

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 in prosthetic rehabilitation.

Inclusive Titanium Abutments are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.

F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Inclusive Titanium Abutments, compatible with Straumann Standard Plus Tissue Level Implants, are substantially equivalent to the ITI synOcta Meso Abutments (K033243) and the Inclusive Titanium Abutment Blanks (K083192). They are substantially equivalent in intended use, materials, design, technological characteristics, and performance.

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Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular graphic on the left, resembling a prism. To the right of the graphic, the word "PRISMATIK" is written in bold, uppercase letters. Below "PRISMATIK", the words "DENTALCRAFT, INC." are written in a smaller font size.

COMPARISON OF DEVICES

PROPOSEDPREDICATE (I)PREDICATE (II)
Inclusive Titanium
Abutments,
compatible with
Straumann Standard
Plus Tissue Level
ImplantsInclusive Titanium
Abutment BlanksITI synOcta Meso
AbutmentsSimilarities
/
Differences
of Devices
ManufacturerPrismatik DentalcraftPrismatik DentalcraftStraumann USA-
510(k) NumberK141211K083192K033243-
Indications
for UseInclusive Titanium
Abutments are
premanufactured
prosthetic components
directly connected to
endosseous dental
implants and are
intended for use as an
aid in prosthetic
rehabilitation.
Inclusive Titanium
Abutments are
compatible with
Straumann Standard
Plus Tissue Level
Implants in RN (4.1
mm and 4.8 mm) and
WN (4.8 mm) sizes.Inclusive Titanium
Abutment Blank is
intended to be used
in conjunction with
endosseous implants
in the maxillary
and/or mandibular
arch to provide
support for crowns,
bridges or
overdenture
prostheses. The
prosthesis can be
cement retained to
the abutment. The
abutment screw is
intended to secure
the abutment to the
endosseous implant.Abutments are
intended to be placed
into dental implants to
provide support for
prosthetic
reconstructions such as
crowns or bridges. The
ITI synOcta Measo
abutments are
indicated for cemented
restorations in esthetic
areas of the mouth. The
abutment can be used
in single tooth
replacements and
multiple tooth
restorations.Same
Intended
Use
Platform
CompatibilityStraumann synOcta-Straumann synOctaSame
Platform
Diameter (mm)RN 4.8 mm
WN 6.5 mm-RN 4.8 mm
WN 6.5 mmSame
Dimensions of
Abutment Screw8 mm long
M2.0 thread-8 mm long
M2.0 threadSame
ConnectionOctagonal-OctagonalSame
Material
(Abutment &
Screw)Titanium Alloy
(ASTM F136)Titanium Alloy
(ASTM F136)Abutment: Unalloyed
Titanium (ASTM F67)
Screw: Titanium AlloySame with
Predicate I.
Similar with
Predicate II.
Design /
ConstructionMachinedMachinedMachinedSame
Abutment Angle0°-20°-Similar
Implant SeatSits on a TaperSits on a TaperSits on a TaperSame
Screw SeatSits on a TaperSits on a TaperSits on a TaperSame

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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.

G. SUMMARY OF NON-CLINICAL TESTING/PERFORMANCE DATA

Non-clinical test data was used to evaluate the proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.

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 testing finished assembled implant/abutment systems of the worst case scenario, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.

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

The testing performed demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.

CONCLUSION FROM THE NON-CLINICAL TESTING/ PERFORMANCE H. DATA

The results of the nonclinical testing performed, demonstrate that Inclusive Titanium Abutments compatible with Straumann Standard Plus Tissue Level Implants perform as well as the predicate devices. Therefore the proposed device is substantially equivalent with the predicate devices cleared for the same intended use.