(294 days)
No
The 510(k) summary describes a physical dental abutment and screw, with no mention of software, algorithms, or any AI/ML related terms or functionalities. The performance studies focus on mechanical testing.
No
The device is described as a prosthetic component and an aid in prosthetic rehabilitation, not as a device used for treating a disease or medical condition.
No.
The device is described as a premanufactured prosthetic component for dental implants, intended to provide support for prosthetic rehabilitation. There is no mention of it being used to identify or diagnose a condition.
No
The device description clearly states that the device is a physical component (abutment) and screw, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that the Inclusive® Zirconia Abutments are "premanufactured prosthetic components directly connected to endosseous dental implants" and are "placed into the dental implant to provide support for a prosthetic restoration." This describes a physical medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation," which is a clinical procedure involving the restoration of missing teeth, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or any other activity typically associated with IVD devices.
Therefore, the Inclusive® Zirconia Abutments are a dental prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
Inclusive® Zirconia Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive® Zirconia Abutments are compatible with the following bone-level implants:
- Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters
- Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters
- Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)
Product codes
NHA
Device Description
Inclusive Zirconia 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 fastened into the implant with a screw.
The purpose of this 510(k) filing is to validate our inclusive abutment screw to be used with our Inclusive® Zirconia Abutments that are compatible with the following bone-level implants:
- Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters
- Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters
- Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)
The predicate device utilizes an OEM abutment screw vs. the inclusive abutment screw used by the proposed device.
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 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 Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems.
The testing performed demonstrated implant to abutment compatibility and has been used to support the substantial equivalence of the subject device to the identified predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 seal of the U.S. Department of Health and Human Services. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2015
Prismatik Dentalcraft, Inc. Mr. Brandon Shepard Regulatory Affairs & Quality Assurance Specialist 2212 Dupont Dr., Suite P Irvine, California 92612
Re: K143515
Trade/Device Name: Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 27, 2015 Received: August 28, 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.
1
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 (OS) 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
2
| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration |
|---------------------------------------------------------------|-------------------------------------------------------------------------|
| Expiration Date: January 31, 2017
See PRA Statement below. | Indications for Use |
| 510(k) Number (if known) | K143515 |
|---|---|
| Device Name | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants. |
| Indications for Use (Describe) | Inclusive® Zirconia Abutments are premanufactured prosthetic components directly connected to endosseous dental |
| implants and are intended for use as an aid in prosthetic rehabilitation. |
Inclusive® Zirconia Abutments are compatible with the following bone-level implants:
Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diametersNobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diametersZimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants) |
| 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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740
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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.
Image /page/3/Picture/1 description: The image shows a blue rectangle with the number 005 in white font. The rectangle is set against a white background. A thin gray line is visible below the blue rectangle, adding a subtle border to the design.
510(k) Summary
[As Required by 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 / Fax: | (949) 225-1269 / (978) 313-0850 |
| Primary Contact Person: | Marilyn Pourazar, (949) 225-1269 |
| Senior Director, RA/QA | |
| Date Summary Prepared: | September 30, 2015 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Inclusive® Zirconia Abutments |
| compatible with: Zimmer Screw-Vent, Biomet 3i | |
| Certain and Nobel Biocare NobelReplace Implants. | |
| Common Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 872.3630 |
| Product Code: | NHA |
| Device Class: | 2 |
IDENTIFICATION OF PREDICATE DEVICE C.
Trade/Proprietary Name:
- · Inclusive Zirconia Abutment Blanks (K083480)
DEVICE DESCRIPTION D.
Inclusive Zirconia Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The
4
Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle with a gradient of colors, ranging from pink to blue to yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. The text is stacked, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
abutment is placed over the implant shoulder and is fastened into the implant with a screw.
The purpose of this 510(k) filing is to validate our inclusive abutment screw to be used with our Inclusive® Zirconia Abutments that are compatible with the following bone-level implants:
- · Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters
- · Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters
- · Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)
The predicate device utilizes an OEM abutment screw vs. the inclusive abutment screw used by the proposed device.
E. INDICATIONS FOR USE
Inclusive® Zirconia Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive® Zirconia Abutments are compatible with the following bone-level implants:
- · Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters
- · Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters
- · Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)
F. NON-CLINICAL TESTING
Non-clinical test data was used to 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. Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems.
5
Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color gradient that includes pink, red, yellow, green, and blue. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue font.
The testing performed demonstrated implant to abutment compatibility and has been used to support the substantial equivalence of the subject device to the identified predicate.
G. SUBSTANTIAL EQUIVALENCE
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants are substantially equivalent to the Inclusive Zirconia Abutment Blanks (K083480) identified in Section C above. They are substantially equivalent in intended use, materials, design and performance. To confirm the substantial equivalence, applicable performance tests such as Static Failure Load Testing and Fatigue Strength Testing have been performed, and the testing results and evaluations demonstrate the compatibility between the proposed and predicate 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) Alloy for Surgical | |
| Implant Applications | |
| AAMI/ANSI/ISO 10993-1:2009 | Biological Evaluation of Medical |
| Devices - Part 1: Evaluation and Testing | |
| within a Risk Management Process | |
| (Biocompatibility) | |
| ISO14801:2007 | Dentistry - Implants - Dynamic fatigue |
| test for endosseous dental implants | |
| AAMI/ANSI 17665:-1:2006 | Sterilization of health care products - |
| Moist Heat - Part 1: Requirements for | |
| the development, validation and routine | |
| control of a sterilization process for | |
| medical devices | |
| AAMI/ANSI/ISO 17665-2:2009 | Sterilization of Health Care Products - |
| Radiation - Part 2: Guidance of on the | |
| application of ISO 17665-1 | |
| ANSI/AAMI ST79:2010 &A1:2010 & | |
| A2:2011 & A3:2012 & A4:2013 | (Consolidated Text) Comprehensive |
| guide to steam sterilization and sterility | |
| assurance in health care facilities |
(See Comparison Tables below).
6
Image /page/6/Picture/0 description: The image contains 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 sections with different colors, including blue, pink, and yellow. The company name is written in a sans-serif font, with "PRISMATIK" on the first line and "DENTALCRAFT, INC." on the second line.
| Attributes | Predicate Device | Proposed Device | |
|---|---|---|---|
| Inclusive Zirconia Abutment | |||
| Blanks | |||
| (K083480) | Inclusive Zirconia Abutments | ||
| compatible with: Zimmer Screw- | |||
| Vent Platform | Similarities and Differences | ||
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Same |
| Dimensions of | |||
| Abutment | Hex Dimensions: | ||
| 2.4mm Across Flats | |||
| 3.0mm Across Flats | Hex Dimensions: | ||
| 2.4mm Across Flats | |||
| 3.0mm Across Flats | Same | ||
| Abutment Screw | |||
| Manufacturer | Zimmer (OEM) | Prismatik Dentalcraft, Inc. | The proposed device includes |
| the inclusive abutment screw | |||
| Dimensions of | |||
| Abutment Screw | Length 9mm; 1-72 UNF-2A Thread | Length 9mm; 1-72 UNF-2A Thread | Same |
| Indications for Use | The Inclusive Zirconia Abutment | ||
| Blank is intended to be used in | |||
| conjunction with endosseous implant | |||
| 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. | Inclusive Zirconia Abutments are | ||
| premanufactured prosthetic | |||
| components directly connected to | |||
| endosseous dental implants and are | |||
| intended for use as an aid in | |||
| prosthetic rehabilitation. | Same Intended Use. | ||
| Platform | |||
| Compatibility | Zimmer Dental Screw-Vent 3.5, 4.5, | ||
| 5.7mm | Zimmer Dental Screw-Vent 3.5, 4.5, | ||
| 5.7mm (not compatible with | |||
| 3.3mmD implant) | Same | ||
| Connection | Internal Hex | Internal Hex | Same |
| Design/Construction | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-20° | 0°-20° | Same |
| Implant Seat | Sits on a taper | Sits on a taper | Same |
| Screw Seat | Sits on a flat | Sits on a flat | Same |
| Material | Zirconia | Zirconia | Same |
Comparison of Predicate and Proposed Devices: Zimmer Screw-Vent Platform
7
| Attributes | Predicate Device | Proposed Device | |
|---|---|---|---|
| Inclusive Zirconia Abutment Blanks | |||
| (K083480) | Inclusive Zirconia Abutments | ||
| compatible with: Biomet 3i Certain | |||
| Implant System | Similarities and Differences | ||
| Manufacturer | Prismatik Dentalcraft. Inc. | Prismatik Dentalcraft, Inc. | Same |
| Dimensions of | |||
| Abutment | Hex Dimensions: | ||
| 2.2mm Across Flats | |||
| 2.7mm Across Flats | Hex Dimensions: | ||
| 2.2mm Across Flats | |||
| 2.7mm Across Flats | Same | ||
| Abutment Screw | |||
| Manufacturer | Biomet 3i (OEM) | Prismatik Dentalcraft, Inc. | The proposed device includes |
| the inclusive abutment screw | |||
| Dimensions of | |||
| Abutment Screw | Length 10mm; M1.6 Thread | Length 10mm; M1.6 Thread | Same |
| Indications for Use | The Inclusive Zirconia Abutment | ||
| Blank is intended to be used in | |||
| conjunction with endosseous implant | |||
| 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. | Inclusive Zirconia Abutments are | ||
| premanufactured prosthetic | |||
| components directly connected to | |||
| endosseous dental implants and are | |||
| intended for use as an aid in prosthetic | |||
| rehabilitation. | Same Intended Use. | ||
| Platform | |||
| Compatibility | Biomet 3i Certain 3.4, 4.1, 5.0, 6.0mm | Biomet 3i Certain 3.4, 4.1, 5.0, 6.0mm | Same |
| Connection | Internal Hex | Internal Hex | Same |
| Design/Construction | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-20° | 0°-20° | Same |
| Implant Seat | Sits on a flat | Sits on a flat | Same |
| Screw Seat | Sits on a flat | Sits on a flat | Same |
| Material | Zirconia | Zirconia | Same |
| Attributes | Predicate Device | Proposed Device | |
| Inclusive Zirconia Abutment | |||
| Blanks | |||
| (K083480) | Inclusive Zirconia Abutments | ||
| compatible with: Nobel Biocare | |||
| NobelReplace Implant System | Similarities and Differences | ||
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Same |
| Dimensions of | |||
| Abutment | Cylindrical Diameter: 9.4mm | ||
| Connection Length: .8mm | Cylindrical Diameter: 9.4mm | ||
| Connection Length: .8mm | Same | ||
| Abutment Screw | |||
| Manufacturer | Nobel Biocare (OEM) | Prismatik Dentalcraft, Inc. | The proposed device includes |
| the inclusive abutment screw | |||
| Dimensions of | |||
| Abutment Screw | Length 8.3mm; M1.8 Thread | Length 8.3mm; M1.8 Thread | Same |
| Indications for Use | The Inclusive Zirconia Abutment | ||
| Blank is intended to be used in | |||
| conjunction with endosseous implant | |||
| 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. | Inclusive Zirconia Abutments are | ||
| premanufactured prosthetic | |||
| components directly connected to | |||
| endosseous dental implants and are | |||
| intended for use as an aid in prosthetic | |||
| rehabilitation. | Same Intended Use. | ||
| Platform | |||
| Compatibility | Nobel Biocare NobelReplace NP, | ||
| RP, WP, 6.0 | Nobel Biocare NobelReplace NP, RP, | ||
| WP, 6.0 | Same | ||
| Connection | Internal Trilobe | Internal Trilobe | Same |
| Design/Construction | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-20° | 0°-20° | Same |
| Implant Seat | Sits on a flat | Sits on a flat | Same |
| Screw Seat | Sits on a flat | Sits on a flat | Same |
| Material | Zirconia | Zirconia | Same |
Comparison of Predicate and Proposed Devices: Biomet 3i Certain Platform
8
Image /page/8/Picture/0 description: The image contains 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 sections of different colors, including pink, red, yellow, green, blue, and purple. The company name is written in a sans-serif font, with the words "PRISMATIK" and "DENTALCRAFT, INC." stacked on top of each other.