(294 days)
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)
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.
The provided document is a 510(k) Pre-market Notification for Inclusive® Zirconia Abutments. This document describes the device and its claimed substantial equivalence to a predicate device, focusing on non-clinical testing. It does not include information on acceptance criteria for a study proving device performance in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study or related effect size.
- Standalone performance (algorithm only).
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to a traditional medical device (dental abutments) and its regulatory clearance through a substantial equivalence pathway, primarily supported by bench testing (fatigue and static load failure testing) in accordance with relevant FDA guidance and ISO standards. It does not involve AI/ML components or associated studies for diagnostic or prognostic performance.
{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 SERVICESFood and Drug Administration |
|---|---|
| Expiration Date: January 31, 2017See 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 dentalimplants 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"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) 443-6740EF |
|---|---|---|
| ---------------------- | ------------- | ---------------------------------------------- |
{3}------------------------------------------------
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 PIrvine, CA 92612 |
| Company Phone / Fax: | (949) 225-1269 / (978) 313-0850 |
| Primary Contact Person: | Marilyn Pourazar, (949) 225-1269Senior Director, RA/QA |
| Date Summary Prepared: | September 30, 2015 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Inclusive® Zirconia Abutmentscompatible with: Zimmer Screw-Vent, Biomet 3iCertain 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 (ExtraLow Interstitial) Alloy for SurgicalImplant Applications |
| AAMI/ANSI/ISO 10993-1:2009 | Biological Evaluation of MedicalDevices - Part 1: Evaluation and Testingwithin a Risk Management Process(Biocompatibility) |
| ISO14801:2007 | Dentistry - Implants - Dynamic fatiguetest for endosseous dental implants |
| AAMI/ANSI 17665👎2006 | Sterilization of health care products -Moist Heat - Part 1: Requirements forthe development, validation and routinecontrol of a sterilization process formedical devices |
| AAMI/ANSI/ISO 17665-2:2009 | Sterilization of Health Care Products -Radiation - Part 2: Guidance of on theapplication of ISO 17665-1 |
| ANSI/AAMI ST79:2010 &A1:2010 &A2:2011 & A3:2012 & A4:2013 | (Consolidated Text) Comprehensiveguide to steam sterilization and sterilityassurance 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 AbutmentBlanks(K083480) | Inclusive Zirconia Abutmentscompatible with: Zimmer Screw-Vent Platform | Similarities and Differences | |
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Same |
| Dimensions ofAbutment | Hex Dimensions:2.4mm Across Flats3.0mm Across Flats | Hex Dimensions:2.4mm Across Flats3.0mm Across Flats | Same |
| Abutment ScrewManufacturer | Zimmer (OEM) | Prismatik Dentalcraft, Inc. | The proposed device includesthe inclusive abutment screw |
| Dimensions ofAbutment Screw | Length 9mm; 1-72 UNF-2A Thread | Length 9mm; 1-72 UNF-2A Thread | Same |
| Indications for Use | The Inclusive Zirconia AbutmentBlank is intended to be used inconjunction with endosseous implantin the maxillary and/or mandibulararch to provide support for crowns,bridges or overdenture prostheses.The prosthesis can be cementretained to the abutment. Theabutment screw is intended to securethe abutment to the endosseousimplant. | Inclusive Zirconia Abutments arepremanufactured prostheticcomponents directly connected toendosseous dental implants and areintended for use as an aid inprosthetic rehabilitation. | Same Intended Use. |
| PlatformCompatibility | Zimmer Dental Screw-Vent 3.5, 4.5,5.7mm | Zimmer Dental Screw-Vent 3.5, 4.5,5.7mm (not compatible with3.3mmD 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 Abutmentscompatible with: Biomet 3i CertainImplant System | Similarities and Differences | |
| Manufacturer | Prismatik Dentalcraft. Inc. | Prismatik Dentalcraft, Inc. | Same |
| Dimensions ofAbutment | Hex Dimensions:2.2mm Across Flats2.7mm Across Flats | Hex Dimensions:2.2mm Across Flats2.7mm Across Flats | Same |
| Abutment ScrewManufacturer | Biomet 3i (OEM) | Prismatik Dentalcraft, Inc. | The proposed device includesthe inclusive abutment screw |
| Dimensions ofAbutment Screw | Length 10mm; M1.6 Thread | Length 10mm; M1.6 Thread | Same |
| Indications for Use | The Inclusive Zirconia AbutmentBlank is intended to be used inconjunction with endosseous implantin the maxillary and/or mandibulararch to provide support for crowns,bridges or overdenture prostheses.The prosthesis can be cement retainedto the abutment. The abutment screwis intended to secure the abutment tothe endosseous implant. | Inclusive Zirconia Abutments arepremanufactured prostheticcomponents directly connected toendosseous dental implants and areintended for use as an aid in prostheticrehabilitation. | Same Intended Use. |
| PlatformCompatibility | 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 AbutmentBlanks(K083480) | Inclusive Zirconia Abutmentscompatible with: Nobel BiocareNobelReplace Implant System | Similarities and Differences | |
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Same |
| Dimensions ofAbutment | Cylindrical Diameter: 9.4mmConnection Length: .8mm | Cylindrical Diameter: 9.4mmConnection Length: .8mm | Same |
| Abutment ScrewManufacturer | Nobel Biocare (OEM) | Prismatik Dentalcraft, Inc. | The proposed device includesthe inclusive abutment screw |
| Dimensions ofAbutment Screw | Length 8.3mm; M1.8 Thread | Length 8.3mm; M1.8 Thread | Same |
| Indications for Use | The Inclusive Zirconia AbutmentBlank is intended to be used inconjunction with endosseous implantin the maxillary and/or mandibulararch to provide support for crowns,bridges or overdenture prostheses.The prosthesis can be cementretained to the abutment. Theabutment screw is intended to securethe abutment to the endosseousimplant. | Inclusive Zirconia Abutments arepremanufactured prostheticcomponents directly connected toendosseous dental implants and areintended for use as an aid in prostheticrehabilitation. | Same Intended Use. |
| PlatformCompatibility | 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.
Comparison of Predicate and Proposed Devices: Nobel Biocare NobelReplace Platform
§ 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.)