(309 days)
No
The summary describes premanufactured and CAD/CAM fabricated dental abutments and copings, with no mention of AI or ML in the device description, intended use, or performance studies. The focus is on material properties, mechanical testing, and compatibility with existing implant systems.
Yes.
The device components are connected to endosseous dental implants to support prosthetic restorations, aiding in prosthetic rehabilitation by reconstructing the function and aesthetics of lost teeth.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as premanufactured prosthetic components designed to provide support for dental restorations. It does not mention any function related to diagnosing medical conditions or diseases. The device's purpose is reconstructive, not diagnostic.
No
The device description clearly states that the device is a premanufactured prosthetic component made from titanium alloy, which is a physical material, not software. While it mentions digitally designed abutments for CAD/CAM, the device itself is the physical abutment.
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 "premanufactured prosthetic component connected to endosseous dental implants... to provide support for cement-retained or screw-retained prosthetic restorations." This describes a device used in vivo (within the body) for structural support, not a device used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description further reinforces its use as a prosthetic component connected to implants for dental rehabilitation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Inclusive® Titanium Abutments are a medical device, but not an In Vitro Diagnostic device.
No
The clearance letter explicitly states: "The 510(k) submission did not include a PCCP."
Intended Use / Indications for Use
Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Product codes
NHA
Device Description
Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Straumann® Bone Level SC Implant System, BioHorizons® Tapered Internal Implant System and MIS® C1 Implant System. The products are made from titanium alloy Ti-6Al-4V ELI, which meets ASTM standard F136. They include Inclusive® Titanium Abutment Blanks intended to fabricate one-piece, alltitanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or zirconia copings. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top half. Each patient-specific abutment is prescribed by a clinician and manufactured by Prismatik Dentalcraft, Inc. or a qualified validated milling center. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.
Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136 and used in conjunction with the OEM BioHorizons® Tapered Internal and OEM MIS® C1 multi-unit abutment. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous or partially edentulous maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Evaluation:
The evaluation followed 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". It was concluded that there is no biocompatibility concern. Additional biocompatibility testing was not conducted as the device has the same material and manufacturing process at the same manufacturing facility as the primary predicate device (K191222) and the reference device (K169079). Cytotoxicity testing according to ISO 10993-5 was referenced from K169079.
Mechanical Properties:
Static load and fatigue testing of the implant/abutment assembly was conducted 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 for its intended use. Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws was performed to confirm compatibility.
Sterilization Validation:
The device is provided non-sterile and intended for steam sterilization by the end user with the same parameters as the primary predicate device (K191222). Additional sterilization validation was not conducted as the device has the same material and manufacturing process at the same manufacturing facility as the primary predicate device (K191222) and the reference device (K160979). Sterilization validation according to ISO 17665-1 was referenced from K083192 and K160979.
Shelf Life and Packaging Validation:
Shelf-life is not applicable as the device is made from titanium alloy conforming to ASTM F136, which is known to be stable at room temperature. A packaging validation according to ASTM D4169-16 was conducted, and the packaging was determined to be suitable for use.
Use in MR Environment:
Non-clinical MR review was performed based on 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) and 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)
Reference Device(s)
K083192, K160979, K162890, K071638, K093321, K143022, K112162, K172505
Predetermined Change Control Plan (PCCP) - All Relevant Information
FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction.
§ 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.
July 25, 2024
Prismatik Dentalcraft, Inc. So Hyun Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 92612
Re: K223496
Trade/Device Name: Inclusive@Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA
Dear So Hyun Park:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on September 26, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Andrew Steen, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, (301) 796-6284、Andrew.Steen@fda.hhs.gov
Sincerely.
Sherrill Lathrop Blitzer
for Andrew 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
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 25, 2024
Prismatik Dentalcraft, Inc. So Hyun Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 92612
Re: K223496
Trade/Device Name: Inclusive@Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal. MIS® C1 Implant Systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 26, 2023 Received: September 26, 2023
Dear So Hyun Park:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on September 26, 2023.
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/cdrb/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.
2
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.
For comprehensive regulatory information about mediation-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,
Sherrill Lathrop Blitzer
Andrew Steen for Assistant Director
3
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
4
Indications for Use
510(k) Number (if known) K223496
Device Name
Inclusiv® Ttanium Abutments compatible with: Strauman® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems
Indications for Use (Describe)
Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Compatible Implant System: Strauman® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1
| Compatible Implant Fixtures | Implant Body Diameter | Implant Platform Diameter |
|---|---|---|
| Straumann® Bone Level SC | 2.9mm | 2.9mm |
| BioHorizons® Tapered Internal | 3.0mm | 3.0mm |
| 3.4mm | 3.0mm | |
| 3.8mm | 3.5mm | |
| 4.6mm | 4.5mm | |
| 5.8mm | 5.7mm | |
| MIS® C1 | 3.3mm | NP (2.75mm) |
| 3.75/4.2mm | SP (3.15mm) | |
| 5.0mm | WP (4.0mm) |
| 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/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side with a gradient of colors, including pink, blue, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in blue 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: Herbert Crane, VP RA/QA Email: Herbert.crane(@glidewelldental.com Phone: (949) 222-3531
Date Prepared: September 26, 2023
II. DEVICE
Name of Device: Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems 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
III. PREDICATE DEVICE
Primary Predicate
Inclusive® Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System® EV (K191222)
Reference Device Inclusive® Titanium Abutment Blanks (K083192) Inclusive® Abutments (K160979) Straumann Ø2.9 mm Bone Level Tapered Implants (K162890) BioHorizons Tapered Internal Implant System (K071638) BioHorizons Laser-Lok 3.0 Implant System (K093321) BioHorizons Tapered Internal Implants (K143022) Conical Connection Implants (K112162) MIS C1 Narrow Platform Conical Connection Implant System (K172505)
DEVICE DESCRIPTION IV.
Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side with a gradient of colors, including pink, blue, yellow, and red. To the right of the triangle is the text "PRISMATIK" in a blue, sans-serif font, with "DENTALCRAFT, INC." below it in the same font and color.
rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Straumann® Bone Level SC Implant System, BioHorizons® Tapered Internal Implant System and MIS® C1 Implant System. The products are made from titanium alloy Ti-6Al-4V ELI, which meets ASTM standard F136. They include Inclusive® Titanium Abutment Blanks intended to fabricate one-piece, alltitanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or zirconia copings. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top half. Each patient-specific abutment is prescribed by a clinician and manufactured by Prismatik Dentalcraft, Inc. or a qualified validated milling center. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.
Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136 and used in conjunction with the OEM BioHorizons® Tapered Internal and OEM MIS® C1 multi-unit abutment. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.
V. INDICATIONS FOR USE
Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Compatible Implant Fixtures Implant Body Diameter Implant Platform Diameter Straumann® Bone Level SC 2.9mm 2.9mm BioHorizons® Tapered Internal 3.0mm 3.0mm 3.4mm 3.0mm 3.8mm 3.5mm 4.5mm 4.6mm 5.8mm 5.7mm MIS® C1 3.3mm NP (2.75mm) 3.75/4.2mm SP (3.15mm) 5.0mm WP (4.0mm)
Compatible Implant Systems: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1
7
Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side that is divided into sections of different colors, including pink, white, blue, yellow, and green. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", written in a blue sans-serif font. The company name is stacked on two lines.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.
| Technological
Characteristics | Subject Device
(K223496) | Predicate Device
(K191222) | Comparison | | | | | | | | | | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| Device Name | Inclusive® Titanium Abutments compatible with:
Straumann® Bone Level SC, BioHorizons® Tapered
Internal, MIS® C1 Implant Systems | Inclusive® Titanium Abutments compatible
with: Dentsply Implants Astra Tech Implant
System® EV | N/A | | | | | | | | | | | | | | | | | | |
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Same | | | | | | | | | | | | | | | | | | |
| Product Code | NHA | NHA | Same | | | | | | | | | | | | | | | | | | |
| Prescription Device | Yes | Yes | Same | | | | | | | | | | | | | | | | | | |
| Intended Use | Inclusive® Abutments are intended for use as an aid in
prosthetic rehabilitation. | Inclusive® Abutments are intended for use as an
aid in prosthetic rehabilitation. | Same | | | | | | | | | | | | | | | | | | |
| Indications for Use | Inclusive® Titanium Abutments are premanufactured
prosthetic components connected to endosseous dental
implants in edentulous or partially edentulous maxilla or
mandible to provide support for cement-retained or
screw-retained prosthetic restorations.
All digitally designed abutments for use with Inclusive®
Titanium Abutments for CAD/CAM are intended to be
sent to a Prismatik Dentalcraft validated milling center
for manufacture.
Compatible Implant Systems: Straumann® Bone Level
SC, BioHorizons® Tapered Internal, MIS® C1 | Inclusive® Titanium Abutments are
premanufactured prosthetic components
connected to endosseous dental implants in
edentulous or partially edentulous maxilla or
mandible to provide support for cement-retained
or screw-retained prosthetic restorations.
All digitally designed abutments for use with
Inclusive® Titanium Abutments for CAD/CAM
are intended to be sent to a Prismatik Dentalcraft
validated milling center for manufacture.
Compatible Implant System: Dentsply Implants
Astra Tech Implant System® EV | Same except
for compatible
platforms | | | | | | | | | | | | | | | | | | |
| | Compatible Implant
Fixtures | Compatible Implant
Fixtures | | | | | | | | | | | | | | | | | | | |
| | Implant
Body
Diameter Implant
Platform
Diameter Straumann® Bone
Level SC 2.9mm 2.9mm BioHorizons® Tapered
Internal 3.0mm 3.0mm | | | | | | | | | | Implant
Body
Diameter Implant
Platform
Diameter OsseoSpeed® EV
3.0S 3.0mm 3.0mm OsseoSpeed® EV
3.6S 3.6mm 3.6mm | | | | | | | | | | |
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Image /page/8/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color gradient that goes from pink to blue. To the right of the triangle is the company name in blue text. The first line says "PRISMATIK" and the second line says "DENTALCRAFT, INC."
| Technological
Characteristics | Subject Device
(K223496) | | | Predicate Device
(K191222) | | | Comparison | | | |
|----------------------------------|-----------------------------|------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------|----------------|-------|-----------------------------------|------|
| | | 3.8mm | 3.5mm | OsseoSpeed® EV
4.2S | | | 4.2mm | 4.2mm | | |
| | | 4.6mm | 4.5mm | OsseoSpeed® EV
4.2C | | | 3.6mm | 4.2mm | | |
| | MIS® C1 | 5.8mm | 5.7mm | OsseoSpeed® EV
4.8S | | | 4.8mm | 4.8mm | | |
| | | 3.3mm | NP (2.75mm) | OsseoSpeed® EV
4.8C | | | 4.2mm | 4.8mm | | |
| | | 3.75/4.2mm | SP (3.15mm) | OsseoSpeed® EV
5.4S | | | 5.4mm | 5.4mm | | |
| | | 5.0mm | WP (4.0mm) | | | | | | | |
| Design Characteristics | Material | Abutment
&Screw | Ti-6Al-4V ELI (ASTM F136) | | | Ti-6Al-4V ELI (ASTM F136) | | | Same | |
| | | Multi-Unit
Coping & Screw | Ti-6Al-4V ELI (ASTM F136) | | | Ti-6Al-4V ELI (ASTM F136) | | | Same | |
| | | Coping/
Superstructure | Y-TZP (ISO 13356) | | | Y-TZP (ISO 13356) | | | Same | |
| | | Cement | Shofu MonoCem resin cement (K020481) | | | Shofu MonoCem resin cement (K020481) | | | Same | |
| | Connection | | Implant | Connection Design | | Taper followed with a six-position indexing
connection feature | | | Different
connection
design | |
| | | | Straumann® Bone
Level SC | Taper followed by four
connection features | | | | | | |
| | | | MIS® C1 | | | | | | | |
| | | | BioHorizons® Tapered
Internal | Taper followed with a
hexagonal connection
feature | | | | | | |
| | | | Titanium Abutment
Blank | Provided in 9.4mm diameter; To machine a patient-
specific, engaging, one-piece abutment | | Provided in 9.4mm diameter; To machine a
patient-specific, engaging, one-piece abutment | | | Same | |
| | | | Prosthetic Post
Height | 4.0 mm minimum | | 4.0 mm minimum | | | Same | |
| | | Margin Height | | 0.5 mm minimum | | | 0.5 mm minimum | | | Same |
| | Gingival Height | | | 6.0 mm maximum | | | 6.0 mm maximum | | | Same |
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Image /page/9/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. The word "PRISMATIK" is on the top line, and "DENTALCRAFT, INC." is on the bottom line.
| Technological
Characteristics | Subject Device
(K223496) | Predicate Device
(K191222) | Comparison |
|----------------------------------|------------------------------------------|------------------------------------------|----------------------------------|
| Angulation | 0° - 30° | 0° - 20° | Increased
angulation
range |
| Prosthetic
Attachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Same |
| Restoration Types | Single-unit, Multi-unit | Single-unit, Multi-unit | Same |
| Titanium Abutment | Engaging/Non-Engaging two-piece abutment | Engaging/Non-Engaging two-piece abutment | Same |
| Prosthetic Post
Height | 4.0 mm minimum | 4.0 mm minimum | Same |
| Margin Height | 0.5 mm minimum | 0.5 mm minimum | Same |
| Gingival Height | 6.0 mm maximum | 6.0 mm maximum | Same |
| Angulation | 0° | 0° | Same |
| Prosthesis
Attachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Same |
| Restoration Type | Single-unit, Multi-unit | Single-unit, Multi-unit | Same |
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Image /page/10/Picture/1 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, red, orange, yellow, green, blue, and purple. The company name is written in a sans-serif font and is blue.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The subject device is substantially equivalent to the primary predicate device (K191222) listed above in intended use, material, design principles and technological characteristics. The subject device and the primary predicate device (K191222) include prefabricated, precision interface (implant/abutment connection) abutments that are manufactured from titanium alloy conforming to ASTM F136. The subject device and the primary predicate device (K191222) include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or zirconia copings. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top half. Each patient-specific abutment is individually prescribed by the clinician and manufactured by Prismatik Dentalcraft, Inc. or a qualified validated milling center.
The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate device (K191222) except the compatible implant system due to different implant connection. Both devices have the same intended use as endosseous dental implant abutments for the support of a prosthesis to restore chewing function.
The subject device designs are substantially equivalent to the corresponding design of the primary predicate device (K191222), including titanium blank abutments and titanium base abutments (engaging and non-engaging). The subject device and the primary predicate device (K191222) are for single-unit or multiple-unit restorations and for cement-retained or screw-retained prostheses. Both devices have internal implant interface connections and are made of titanium alloy Ti-6Al-4V conforming to ASTM F136 (abutments and abutment screws), and the titanium base abutments are to be used with zirconia superstructures.
The subject device includes designs for abutment angulation up to 30°; this angulation range is similar to the primary predicate device (K191222), but increased angulation range from 20° to 30°. The subject device is compatible with the following OEM implant systems, Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1, and the compatibility of the subject device and the OEM implants was established by dimensional analysis and reverse engineering analysis regarding specific critical dimensions. When the subject device is used according to its labeling, this difference does not impact safety or effectiveness. Furthermore, 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 for its intended use.
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 primary predicate device (K191222), and the reference devices K083192 and K160979. Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component
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Image /page/11/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side, filled with a gradient of colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. The text is arranged in two lines, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
interactions, and storage conditions to the primary predicate device (K191222) and the reference device (K160979). The biological evaluation was also performed on the subject device and concluded that there is no biocompatibility concern.
VII. PERFORMANCE DATA
Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission.
Biocompatibility Evaluation
Biocompatibility evaluation 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. The subject device has the same material and manufacturing process at the same manufacturing facility as the primary predicate device (K191222) and the reference device (K169079); therefore, additional biocompatibility testing was not conducted. Cytotoxicity testing according to ISO 10993-5 was referenced from K169079 to demonstrate the biocompatibility of the final finished device consisting of the titanium abutment, zirconia coping and cement. Biological evaluation was used to address questions related to substantial equivalence between the subject device and the primary predicate device (K191222) in terms of biocompatibility.
Mechanical Properties
Static load and fatigue testing of the implant/abutment assembly was considered 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 for its intended use. Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws was conducted to confirm compatibility. 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 (K191222).
Sterilization Validation
The subject device is provided non-sterile intended to be steam sterilized by the end user with the same parameters as the primary predicate device (K191222). The subject device has the same material and manufacturing process at the same manufacturing facility as the primary predicate device (K191222) and the reference device (K160979); therefore, additional sterilization validation was not conducted. Sterilization validation according to ISO 17665-1 was referenced from K083192 and K160979. The results of the previous testing were used to address questions related to substantial equivalence based on the
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Image /page/12/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. To the right of the triangle, the words "PRISMATIK" and "DENTALCRAFT, INC." are written in blue, with "PRISMATIK" on top of "DENTALCRAFT, INC."
differences in technical specifications between the subject device and the primary predicate device (K191222).
Shelf Life and Packaging Validation
The subject device performance 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 air at room temperature for an indefinite period of time. Shelf-life is not applicable because of low likelihood of time-dependent product degradation. A packaging validation according to ASTM D4169-16 was conducted to ensure that the packaging configurations for the subject device are suitable to withstand the distribution environment. It was determined that the packaging for the subject device is suitable for use. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject device and the primary predicate device (K191222).
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 predicate device (K191222).