(320 days)
No
The summary describes a CAD/CAM workflow for designing and milling dental abutments, which is a digital process but does not explicitly mention or imply the use of AI or ML for tasks like design optimization, image analysis, or predictive modeling. The software mentioned is for design, not AI/ML.
No
The device is a prosthetic component (abutment crown) used in dental implant rehabilitation to restore chewing function, not to treat or cure a disease or condition.
No
Explanation: The device is described as a "pre-manufactured prosthetic component directly connected to an endosseous implant" and is "intended for use in prosthetic rehabilitation." Its function is to "restore chewing function" and to be "mounted onto the implant and fixed with a screw." There is no mention of it being used to detect, diagnose, or identify a disease or condition.
No
The device is a physical dental abutment made of zirconia and titanium, not solely software. While it is designed and fabricated using a digital workflow involving software, the device itself is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "pre-manufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and restoration of function.
- Device Description: The description reinforces this by explaining it's a "two-piece hybrid abutment crown" used "in conjunction with endosseous dental implants to restore chewing function."
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the human body. IVDs are specifically designed for these purposes.
- Anatomical Site: The anatomical site is an "endosseous implant," which is within the body. IVDs typically interact with in vitro samples.
Therefore, the BruxZir® NOW SRC is a medical device, but it falls under the category of a prosthetic or restorative device used in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intra-oral scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional and dental laboratories / in-office
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)
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 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 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".
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.
On1TM Universal Abutment (K181869)
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.
BruxZir® NOW (K220816), Hahn™ Tapered Implant System (K143353), Inclusive® Tapered Implant System (K121406, K153099), Inclusive® Abutments (K160979), Pulpdent Post Cement (K020481)
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/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.
1
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.
2
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
3
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:
| Design
Parameter | Platform
Diameter
(mm) | Minimum (mm) | | Maximum (mm) |
|---------------------|------------------------------|-----------------------------|-----------------------------|---------------------------|
| | | Below
Gingival
Margin | Above
Gingival
Margin | Maximum Edge
Thickness |
| 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.
| Design
Parameter | Platform
Diameter
(mm) | Minimum
(mm) | Maximum
(mm) |
|---------------------------------------------------------------|------------------------------|-----------------|-----------------|
| Total Abutment
Height
including
Emergence
Profile | 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 |
| Design
Parameter | Platform
Diameter
(mm) | Minimum
(mm) | Maximum
(mm) |
|---------------------------------------------------------------------------|------------------------------|-----------------|-----------------|
| Abutment Post
Height above
the Minimum
Gingival Collar
Height | Hahn 3.5/4.3 | 4.2 | 13.7 |
| | Hahn 5.0 | | |
| | Hahn 7.0 | | |
| | Inclusive 3.0 | | |
| | Inclusive 3.5 | | |
| | Inclusive 4.5 | | |
| Design
Parameter | Platform
Diameter
(mm) | Minimum
(mm) | Maximum
(mm) |
|---------------------------|------------------------------|-----------------|-----------------|
| Gingival Collar
Height | 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
| | Technological
Characteristics | 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 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. The system
integrates multiple components
of the digital dentistry
workflow: scan files from Intra-
Oral Scanners, CAD software,
CAM software, ceramic
material, milling machine and
associated tooling and
accessories. | The On1™ device is a
premanufactured prosthetic
component directly connected to
an endosseous implant and it is
intended for use in prosthetic
rehabilitation.
The On1™ Universal Abutment
consists of three major parts.
Specifically, the On1™ Base,
the On1™ Universal Abutment,
and the mesostructure
components make up a multi-
piece abutment. The system
integrates multiple components
of the digital dentistry workflow:
scan files from Intra-Oral
Scanners, CAD software, CAM
software, ceramic material,
milling machine and associated
tooling and accessories. | Same except for the
device trade name and
components.
The subject device
consists of two major
parts versus the predicate
device that consists of
three major parts.
The differences do not
affect the intended use of
the device. |
| | Design
Characteristics
Material
Composition | Abutment Base:
Titanium Alloy
(ASTM F136) | Abutment Base:
Titanium Alloy
(ASTM F136) | The subject device
utilizes the same material
for the abutment base, but
different mesostructure/
crown material. The
differences in material
composition do not affect
the safety and
effectiveness of the
subject device. |
| | | Mesostructure/Crown Material:
Yttria-stabilized zirconia (YSZ)
and colorants (K220816) | Mesostructure/Crown Material:
Enamic (K153645) composed of
feldspar 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.
| Technological
Characteristics | Subject Device:
(K231940) | Predicate Device:
(K181869) | Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Mesostructure/
Crown Fixation | Bonded | Bonded | Same |
| Abutment
Design | 2-piece abutment with a fully
sintered zirconia superstructure
and a pre-installed Titanium
base. This two-piece abutment
is mounted on to the implant
and fixed with a screw. | 2-piece abutment on On1™ Base
– Enamic (K153645) bonded to
the On1™ Universal Abutment
and mounted on to the On1™
Base (K161655). On1™ Base is
mounted on to the implant and
fixed with a screw. | Similar design |
| Abutment
Fixation | Screwed | Screwed | Same |
| Maximum
Angle
Correction | 20° | 20° | Same |
| Abutment Post
Height | 4.2mm min | 5.2mm min | |
| Gingival Collar
Height | 0.95mm min for Hahn 3.5/4.3,
Hahn 5.0, Hahn 7.0, Inclusive
3.0
0.5mm min for Inclusive 3.5
0.55mm min for Inclusive 4.5 | N/A | Different; The differences
in the design parameters
are supported by the
mechanical testing. |
| Wall Thickness | 0.5mm min above gingival
margin | 0.8mm min wall thickness
circular
0.275mm min for wall thickness
margin | |
| Biocompatibility | Biocompatible per ISO 10993-1 | Biocompatible per ISO 10993-1 | Same |
| Design
Workflow | Intra-oral scanner
CloudPoint FastDesign
Chairside Software (K231529) | 3Shape intra-oral scanner Trios
3Shape Abutment Designer
Software (K151455) | Same design workflow
except for using different
scanner and design
software |
| Manufacturing
Workflow | fastmill.io™ In-Office Mill | CORiTEC Milling Unit | Same manufacturing
workflow except for using
different 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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Image /page/11/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color wheel inside. To the right of the triangle is the company name in blue text.
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).