(320 days)
BruxZir® NOW SRC is a pre-manufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. BruxZir® NOW SRC consists of two major parts. Specifically, the precemented titanium abutment and zirconia superstructure components make up a two-piece abutment. All digitally designed CAD/CAM customizations for BruxZZir® NOW SRC are only intended to be designed and manufactured according to digital dentistry workflow, which incorporates of the digital dentistry workflow including scan files from Intra-Oral Scanners, CAD software, milling machine and associated tooling and accessories.
BruxZir® NOW SRC is a pre-manufactured two-piece hybrid abutment crown composed of a fully sintered zirconia superstructure and a pre-installed Ti-base (titanium base) that is used with the glidewell.io™ In-Office Solution. The zirconia and Ti-base components make up a two-piece abutment, which is used in conjunction with endosseous dental implants to restore chewing function. The CAD/CAM software is intended to design the final abutment shape including anatomic features and facilitate in-office milling.
The Ti-base of BruxZir® NOW SRC is pre-cemented to a post-sintered zirconia superstructure, which is to be designed and fabricated to support screw-retained prosthetic restorations. After machining in the fastmill.io"M In-Office Mill, this two-piece abutment is mounted onto the implant and fixed with a screw. BruxZir® NOW SRC can be milled in-office by a dental professional and dental laboratories.
The digital workflow requires the use of the following equipment:
- Scanner: Intra-oral scanner
- Design Software: CloudPoint FastDesign Chairside (K231529)
- Restorative Material: Fully sintered zirconia; BruxZir® NOW(K220816)
- Milling Unit: fastmill.io™ In-Office Mill
The BruxZir® NOW SRC is designed and fabricated to be compatible with the Hahn™ Tapered Implant System (K143353) and the Inclusive® Tapered Implant System (K121406, K153099). BruxZir® NOW SRC is provided non-sterile and intended for single use and prescription use.
The provided text describes the BruxZir® NOW SRC, a dental implant abutment, and its substantial equivalence to a predicate device. It primarily focuses on mechanical, sterilization, biocompatibility, shelf-life, and packaging data to support its claims. There is no information provided in the document about acceptance criteria, device performance, AI/algorithm studies, ground truth establishment, or expert involvement. The document primarily reports on non-clinical testing.
Here's a breakdown of what CANNOT be answered based on the provided text:
- Acceptance criteria and reported device performance (in the context of clinical or AI performance): The document doesn't define specific acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as it's not evaluating an AI/diagnostic device. It broadly states the device has "sufficient strength" and provides a "maximum angulation correction of 20 degrees" based on mechanical testing.
- Sample size for test set and data provenance (for AI): Not applicable as there is no AI or clinical test set described.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used (for AI/clinical performance): Not applicable.
- Sample size for the training set (for AI): Not applicable.
- How the ground truth for the training set was established (for AI): Not applicable.
However, I can extract information about the non-clinical studies performed and their general conclusions:
Non-Clinical Studies and Findings:
| Study Category | Acceptance Criteria / Standard Followed | Reported Device Performance / Conclusion |
|---|---|---|
| Mechanical Properties | FDA Guidance Document, "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801:2016 standard. Testing performed with worst-case scenario. | The fatigue limit data demonstrated that the subject device has sufficient strength and provides a maximum angulation correction of 20 degrees for its intended use. Used to address substantial equivalence. |
| Sterilization Validation | ISO 17665-1:2006 (for steam sterilization). Compared to reference device (Inclusive® Abutments, K160979) which had previous validation. | The steam sterilization parameters previously validated for the reference device (K160979) can sufficiently sterilize the subject device for use in a clinical environment, indicating it meets the criteria. |
| Biocompatibility Evaluation | FDA Guidance Document, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process'." | Concluded that there is no biocompatibility concern. |
| Shelf Life | Based on material stability (titanium alloy conforming to ASTM F136 and Zirconium Oxide). | Shelf-life is not applicable due to the inherent stability of the materials, and no new safety or effectiveness concerns were raised due to aging. |
| Packaging Validation | Evaluated suitability to withstand distribution environment. Compared to reference device (BruxZir® NOW, K220816). | The results of previous packaging validation for the reference device supported the packaging for the subject device, indicating it can withstand distribution without damage. |
| Use in MR Environment | FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and published literature. | Non-clinical MR review performed using scientific rationale; indicates suitability or safety within an MR environment. (Specific parameters not detailed, but the review was conducted). |
Sample Sizes and Data Provenance for Non-Clinical Tests:
- Mechanical Testing: The document refers to "worst-case scenario" testing but does not specify the number of samples or the origin of the data. It's implicitly laboratory-based data for device components.
- Sterilization Validation: Refers to "testing sample used in the previous steam sterilization validation testing for the reference device (K160979)" which "represented the worst-case scenario." No specific number is given for the subject device itself.
- Biocompatibility Evaluation: This is a biological evaluation following ISO 10993-1. Sample size not specified.
- Shelf Life: Based on material science principles; no direct sample size for testing is implied.
- Packaging Validation: "Previous packaging validation" for a reference device was used. No specific sample size for the subject device's packaging.
- MR Environment: Based on scientific rationale and published literature; not a direct experimental study with a sample size for this submission.
Further Notes:
- The document states "No clinical data was included in this submission." This explicitly confirms that the information requested about clinical performance, expert ground truth, and reader studies is not present in this document.
- The device is a "pre-manufactured prosthetic component" for dental implants, not an AI or diagnostic software. Therefore, the questions related to AI-specific performance metrics, training/test sets, and ground truth are not applicable to the scope of this FDA submission.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Prismatik Dentalcraft, Inc. So Park Regulatory Affairs Manager 2144 Michelson Drive Irvine. California 92612
May 15, 2024
Re: K231940
Trade/Device Name: BruxZir® NOW SRC Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: April 11, 2024 Received: April 15, 2024
Dear So Park:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231940
Device Name BruxZir® NOW SRC
Indications for Use (Describe)
BruxZir® NOW SRC is a pre-manufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. BruxZir® NOW SRC consists of two major parts. Specifically, the precemented titanium abutment and zirconia superstructure components make up a two-piece abutment. All digitally designed CAD/CAM customizations for BruxZir® NOW SRC are only intended to be designed and manufactured according to digital dentistry workflow, which incorporates of the digital dentistry workflow including scan files from Intra-Oral Scanners, CAD software, milling machine and associated tooling and accessories.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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 on the left side. The text "PRISMATIK DENTALCRAFT, INC." is on the right side of the triangle. The text is in a blue sans-serif font.
510(k) Summary
I. SUBMITTER
Prismatik Dentalcraft, Inc. 2144 Michelson Drive. Irvine, CA 92612, USA
Primary Contact Person: So Hyun Park, Regulatory Affairs Manager, MS Email: so.park(@glidewelldental.com Phone: (949) 863-5479
Secondary Contact Person: Maria Wagner, Sr. Regulatory Affairs Manager Email: maria.wagner(@glidewelldental.com Phone: (949) 838-1321
Date Prepared: May 15, 2024
II. DEVICE
Name of Device: BruxZir® NOW SRC Common Name or Usual Name: Dental Implant Abutment Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3630) Regulatory Class: Class II Product Code: NHA, PNP
III. PREDICATE DEVICE
Primary Predicate On1TM Universal Abutment (K181869)
Reference Device(s) BruxZir® NOW (K220816) Hahn™ Tapered Implant System (K143353) Inclusive® Tapered Implant System (K121406, K153099) Inclusive® Abutments (K160979) Pulpdent Post Cement (K020481)
IV. DEVICE DESCRIPTION
BruxZir® NOW SRC is a pre-manufactured two-piece hybrid abutment crown composed of a fully sintered zirconia superstructure and a pre-installed Ti-base (titanium base) that is used with the glidewell.io™ In-Office Solution. The zirconia and Ti-base components make up a two-piece abutment, which is used in conjunction with endosseous dental implants to restore chewing function. The CAD/CAM software is intended to design the final abutment shape including anatomic features and facilitate in-office milling.
The Ti-base of BruxZir® NOW SRC is pre-cemented to a post-sintered zirconia superstructure, which is to be designed and fabricated to support screw-retained prosthetic restorations. After machining in the fastmill.io"M In-Office Mill, this two-piece
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Image /page/5/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 sections of different colors, including pink, blue, and yellow. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
abutment is mounted onto the implant and fixed with a screw. BruxZir® NOW SRC can be milled in-office by a dental professional and dental laboratories.
The digital workflow requires the use of the following equipment:
- Scanner: Intra-oral scanner -
- Design Software: CloudPoint FastDesign Chairside (K231529) -
- Restorative Material: Fully sintered zirconia; BruxZir® NOW(K220816) -
- -Milling Unit: fastmill.io™ In-Office Mill
The BruxZir® NOW SRC is designed and fabricated to be compatible with the Hahn™ Tapered Implant System (K143353) and the Inclusive® Tapered Implant System (K121406, K153099). BruxZir® NOW SRC is provided non-sterile and intended for single use and prescription use.
| Implant System | Implant Ø | Platform Ø | 510(k) |
|---|---|---|---|
| HahnTM Tapered Implant System | Ø3.5 mm | Ø3.5/4.3 mm | K143353 |
| Ø4.3 mm | Ø3.5/4.3 mm | ||
| Ø5.0 mm | Ø5.0 mm | ||
| Ø7.0 mm | Ø7.0 mm | ||
| Inclusive® Tapered Implant System | Ø3.2 mm | Ø3.0 mm | K121406 |
| Ø3.7 mm | Ø3.5 mm | K153099 | |
| Ø4.2 mm | Ø3.5 mm | ||
| Ø4.7 mm | Ø4.5 mm | ||
| Ø5.2 mm | Ø4.5 mm |
Compatible Implant Systems:
The following restorative design specifications are required:
| DesignParameter | PlatformDiameter(mm) | Minimum (mm) | Maximum (mm) | |
|---|---|---|---|---|
| BelowGingivalMargin | AboveGingivalMargin | Maximum EdgeThickness | ||
| Wall Thickness | Hahn 3.5/4.3 | 0.25 | 0.5 | 6.975 |
| Wall Thickness | Hahn 5.0 | 0.35 | 0.5 | 6.875 |
| Wall Thickness | Hahn 7.0 | 0.6 | 0.5 | 6.575 |
| Wall Thickness | Inclusive 3.0 | 0.2 | 0.5 | 7.1 |
| Wall Thickness | Inclusive 3.5 | 0.275 | 0.5 | 6.975 |
| Wall Thickness | Inclusive 4.5 | 0.625 | 0.5 | 6.875 |
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Image /page/6/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.
| DesignParameter | PlatformDiameter(mm) | Minimum(mm) | Maximum(mm) |
|---|---|---|---|
| Total AbutmentHeightincludingEmergenceProfile | Hahn 3.5/4.3 | 5.15 | 14.65 |
| Hahn 5.0 | |||
| Hahn 7.0 | |||
| Inclusive 3.0 | |||
| Inclusive 3.5 | 4.7 | 14.2 | |
| Inclusive 4.5 | 4.75 | 14.25 |
| DesignParameter | PlatformDiameter(mm) | Minimum(mm) | Maximum(mm) |
|---|---|---|---|
| Abutment PostHeight abovethe MinimumGingival CollarHeight | Hahn 3.5/4.3 | 4.2 | 13.7 |
| Hahn 5.0 | |||
| Hahn 7.0 | |||
| Inclusive 3.0 | |||
| Inclusive 3.5 | |||
| Inclusive 4.5 |
| DesignParameter | PlatformDiameter(mm) | Minimum(mm) | Maximum(mm) |
|---|---|---|---|
| Gingival CollarHeight | Hahn 3.5/4.3 | 0.95 | 5.15 |
| Hahn 5.0 | |||
| Hahn 7.0 | |||
| Inclusive 3.0 | |||
| Inclusive 3.5 | 0.5 | 4.7 | |
| Inclusive 4.5 | 0.55 | 4.75 |
- Maximum angle correction is no greater than 20 degrees. ●
- . Minimum post height above the gingival collar is no less than 4.2mm
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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, ranging from blue to pink. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", in blue text.
BruxZir® NOW SRC is a pre-manufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. BruxZir® NOW SRC consists of two major parts. Specifically, the pre-cemented titanium abutment and zirconia superstructure components make up a two-piece abutment. All digitally designed CAD/CAM customizations for BruxZir® NOW SRC are only intended to be designed and manufactured according to digital dentistry workflow, which incorporates multiple components of the digital dentistry workflow including scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| TechnologicalCharacteristics | Subject Device:(K231940) | Predicate Device:(K181869) | Comparison | |
|---|---|---|---|---|
| Device Name | BruxZir® NOW SRC | On1™ Universal Abutment | N/A | |
| Manufacturer | Prismatik Dentalcraft, Inc. | Nobel Biocare USA, LLC | N/A | |
| Product Code | NHA | NHA | Same | |
| Prescription Device | Yes | Yes | Same | |
| Indications for Use | BruxZir® NOW SRC is a pre-manufactured prostheticcomponent directly connectedto an endosseous implant and itis intended for use in prostheticrehabilitation. BruxZir® NOWSRC consists of two majorparts. Specifically, the pre-cemented titanium abutmentand zirconia superstructurecomponents make up a two-piece abutment. The systemintegrates multiple componentsof the digital dentistryworkflow: scan files from Intra-Oral Scanners, CAD software,CAM software, ceramicmaterial, milling machine andassociated tooling andaccessories. | The On1™ device is apremanufactured prostheticcomponent directly connected toan endosseous implant and it isintended for use in prostheticrehabilitation.The On1™ Universal Abutmentconsists of three major parts.Specifically, the On1™ Base,the On1™ Universal Abutment,and the mesostructurecomponents make up a multi-piece abutment. The systemintegrates multiple componentsof the digital dentistry workflow:scan files from Intra-OralScanners, CAD software, CAMsoftware, ceramic material,milling machine and associatedtooling and accessories. | Same except for thedevice trade name andcomponents.The subject deviceconsists of two majorparts versus the predicatedevice that consists ofthree major parts.The differences do notaffect the intended use ofthe device. | |
| DesignCharacteristicsMaterialComposition | Abutment Base:Titanium Alloy(ASTM F136) | Abutment Base:Titanium Alloy(ASTM F136) | The subject deviceutilizes the same materialfor the abutment base, butdifferent mesostructure/crown material. Thedifferences in materialcomposition do not affectthe safety andeffectiveness of thesubject device. | |
| Mesostructure/Crown Material:Yttria-stabilized zirconia (YSZ)and colorants (K220816) | Mesostructure/Crown Material:Enamic (K153645) composed offeldspar ceramic and polymer |
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Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the company name written in blue on the right side. The word "PRISMATIK" is on the top line, and "DENTALCRAFT, INC." is on the bottom line.
| TechnologicalCharacteristics | Subject Device:(K231940) | Predicate Device:(K181869) | Comparison |
|---|---|---|---|
| Mesostructure/Crown Fixation | Bonded | Bonded | Same |
| AbutmentDesign | 2-piece abutment with a fullysintered zirconia superstructureand a pre-installed Titaniumbase. This two-piece abutmentis mounted on to the implantand fixed with a screw. | 2-piece abutment on On1™ Base– Enamic (K153645) bonded tothe On1™ Universal Abutmentand mounted on to the On1™Base (K161655). On1™ Base ismounted on to the implant andfixed with a screw. | Similar design |
| AbutmentFixation | Screwed | Screwed | Same |
| MaximumAngleCorrection | 20° | 20° | Same |
| Abutment PostHeight | 4.2mm min | 5.2mm min | |
| Gingival CollarHeight | 0.95mm min for Hahn 3.5/4.3,Hahn 5.0, Hahn 7.0, Inclusive3.00.5mm min for Inclusive 3.50.55mm min for Inclusive 4.5 | N/A | Different; The differencesin the design parametersare supported by themechanical testing. |
| Wall Thickness | 0.5mm min above gingivalmargin | 0.8mm min wall thicknesscircular0.275mm min for wall thicknessmargin | |
| Biocompatibility | Biocompatible per ISO 10993-1 | Biocompatible per ISO 10993-1 | Same |
| DesignWorkflow | Intra-oral scannerCloudPoint FastDesignChairside Software (K231529) | 3Shape intra-oral scanner Trios3Shape Abutment DesignerSoftware (K151455) | Same design workflowexcept for using differentscanner and designsoftware |
| ManufacturingWorkflow | fastmill.io™ In-Office Mill | CORiTEC Milling Unit | Same manufacturingworkflow except for usingdifferent milling machine. |
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The subject device, BruxZir® NOW SRC, is substantially equivalent to the primary predicate device, On1TM Universal Abutment (K181869), in intended use, design principles and technological characteristics.
The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate device (K181869) except for the device trade name and components. Both devices have the same intended use as endosseous dental implant abutments for the support of prosthetic rehabilitation to restore chewing function.
The subject device designs and fundamental principle of operation are substantially equivalent to the primary predicate device (K181869). Both devices consist of a titanium abutment
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Image /page/9/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.
component and a mesostructure or abutment crown. They utilize titanium alloy conforming to ASTM F135 for the abutment base. A mesostructure or abutment crown of the subject device is manufactured from yttria-stabilized zirconia, which has the reference device, BruxZir® NOW (K220816) whereas the primary predicate device (K181869) is composed of Enamic (K153645) material. Furthermore, both devices feature screwed abutment fixation. The patient-specific two-piece abutments consist of prefabricated "Ti-base" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system. The subject device, BruxZir® NOW SRC, is compatible with Hahn™ Tapered Implant System (K143353) and Inclusive® Tapered Implant System (K121406, K153099) whereas the primary predicate device, On1™ Universal Abutment (K181869), is designed to connect directly to the On1TM Base of the On1TM Concept (K161655), which connects to Nobel Biocare dental implants. The subject device allows for a maximum abutment angulation correction of 20 degrees as same as the primary predicate device (K181869). Mechanical performance testing was performed according to ISO 14801:2016, Dentistry - Implants - Dynamic loading test for endosseous dental implants and demonstrated that the subject device has sufficient strength and provides a maximum angulation correction of 20 degrees for its intended use. When the subject device is used according to its labeling, this difference does not impact safety or effectiveness.
The subject device and the primary predicate device (K181869) are intended for CAD/CAM workflows. The digital workflow for both devices require the use of the following equipment, intra-oral scanner, design software, milling unit to produce the mesostructure or abutment crown. The subject device and the primary predicate device (K181869) utilize different equipment, but the fundamental design and manufacturing workflow is the same. Therefore, the differences in design software and manufacturing equipment do not impact demonstrating the substantial equivalence of the subject device to the primary predicate device (K181869).
The subject device is provided non-sterile and to be steam sterilized by the end-user. The validated moist heat sterilization method according to ISO 17665-1:2006 is the same as the reference device, Inclusive® Abutments (K160979). Furthermore, the biological evaluation was performed on the subject device according to ISO 10993-1:2018 and concluded that there is no biocompatibility concern.
As detailed throughout this premarket notification and summarized in the table above, applicable data supports and demonstrates substantial equivalency to the primary predicate device, On11M Universal Abutment (K181869). The differences do not raise new safety and effectiveness questions as compared to the legally marketed device.
VII. PERFORMANCE DATA
Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission.
Mechanical Properties
Static load and fatigue testing of the implant/abutment assembly was performed according to the FDA Guidance Document, Guidance for Industry and FDA Staff Class II Special
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Image /page/10/Picture/0 description: The image contains 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.
Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2016 standard with the worst-case scenario. The fatigue limit data demonstrated that the subject device has sufficient strength and provides a maximum angulation correction of 20 degrees for its intended use. The results of the mechanical testing were used to address questions related to substantial equivalence based on the differences in technical specifications between the subject device and the primary predicate device (K181869).
Sterilization Validation
The subject device, BruxZir® NOW SRC, is provided non-sterile and is intended to be steam sterilized by the end-user with the same parameters as the reference device. Inclusive Abutments (K160979). Both devices are similar in terms of intended use, materials, and manufacturing process. The testing sample used in the previous steam sterilization validation testing for the reference device (K160979) represented the worst-case scenario in terms of weight and surface area when compared to the subject device. Therefore, the steam sterilization parameters previously validated for the reference device (K160979) can sufficiently sterilize the subject device for use in a clinical environment. The results of the previous testing were used to address questions related to substantial equivalence based on the differences in technical specifications between the subject device and the primary predicate device, On1™ Universal Abutment (K181869).
Biocompatibility Evaluation
Biocompatibility evaluation on the subject device, BruxZir® NOW SRC, was conducted by following the FDA Guidance Document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and concluded that there is no biocompatibility concern. Biological evaluation was used to address questions related to device safety in terms of biocompatibility.
Shelf Life
The performance of the subject device, BruxZir® NOW SRC, is not adversely affected by aging because the subject device is made from titanium alloy conforming to ASTM F136. This material is known to be stable in the air at room temperature for an indefinite period of time. Also, due to the stability of Zirconium Oxide, shelf-life is not applicable because of the low likelihood of time-dependent product degradation. Use of this shelf life for BruxZir® NOW SRC raises no new concerns of safety and effectiveness of the device.
Packaging Validation
Packaging configurations were evaluated to ensure that it is suitable to withstand the distribution environment such that the packaged device can be shipped to a customer undamaged. The subject device uses the same packaging materials and packaging configurations as the reference device, BruxZir® NOW (K220816). The results of the previous packaging validation were used to address questions related to substantial
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equivalence based on differences in packaging configuration between the subject device, BruxZir® NOW SRC, and the primary predicate device, On1TM Universal Abutment (K181869).
Use in MR Environment
Non-clinical MR review was performed to evaluate the metallic devices in the MR environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the subject device components and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
CONCLUSION VIII.
Based on the technological characteristics and non-clinical test data included in this submission, the subject device has been shown to be substantially equivalent to the primary predicate device (K181869).
§ 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.)