(205 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterilization efficacy, and durability of a medical device cassette, with no mention of AI or ML technologies.
No.
The device is designed to organize, protect, and sterilize surgical and prosthetic instruments; it does not directly treat or diagnose a disease or condition.
No
The device is described as an autoclavable cassette used to organize and protect surgical and prosthetic instruments during sterilization, storage, and transport. Its function is to facilitate the sterilization process and maintain the organization of instruments, not to diagnose medical conditions or provide diagnostic information.
No
The device is a physical product (cassette) made of polyphenylsulfone PPSU and silicone rubber, designed to hold and organize surgical instruments. It undergoes physical cleaning, sterilization, and packaging validation, not software-specific testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Autoclavable Cassettes are used to organize surgical and prosthetic instruments during sterilization, storage, and transport. This is a function related to the handling and preparation of medical devices, not the testing of biological samples or the diagnosis of diseases.
- Device Description: The description focuses on the physical components and materials of the cassette, its purpose in holding instruments, and its role in the sterilization process. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions
- Using reagents or test kits
The device's function is entirely focused on the physical management and sterilization of surgical instruments, which falls under the category of medical devices used in healthcare procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.
Sterilization parameters:
Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.
Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface.
Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
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)
| Type of Testing | Test Purpose | Acceptance Criteria | Test Result |
|---|---|---|---|
| Manual Cleaning Validation (ANSI/AAMI ST98:2022) | Evaluate and validate the manual cleaning of the subject device | Visual Inspection: No visible soil Hemoglobin Test: 70%, which is considered non-cytotoxic. | Pass |
| Packaging Validation (ASTM D4169-23e1) | Packaging performance testing | Packaging must withstand the distribution environment | Pass |
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.
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.
Not Found
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
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 21, 2025
Prismatik Dentalcraft, Inc. Haiyan Wei Principal Regulatory Affairs Specialist 2144 Michelson Drive Irvine, California 92612
Re: K242564
Trade/Device Name: Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HTTM Implant Surgical Kit, Glidewell™ Prosthetic Kit) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 18, 2025 Received: February 18, 2025
Dear Haiyan Wei:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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,
Stephen A. Digitally signed by
Stephen A. Anisko -S
Anisko -S Date: 2025.03.21
14:49:15 -04'00'
for: Christopher K. Dugard, M.S. Division Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242564
Device Name
Autoclavable Cassette (Glidewell HTM Implant Guidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
Indications for Use (Describe)
The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.
Sterilization parameters:
Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.
Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a color gradient that starts with pink at the top, transitions to blue in the middle, and ends with yellow at the bottom. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", written in a blue sans-serif font.
510(k) Summary K242564
Submission Date: February 18, 2025
I. Contact Details
Applicant Name: Prismatik Dentalcraft, Inc.
Address: 2144 Michelson Drive, Irvine, CA 92612 United States
Applicant Contact: Ms. Haiyan Wei, Principal Regulatory Affairs Specialist
Email: Haiyan.Wei@glidewelldental.com
Phone: 949-399-1984
Secondary Contact: Ms. So Hyun Park, Regulatory Affairs Manager
Email: So.Park(@glidewelldental.com
Phone: 949-863-5479
II. Device Name
Device Trade Name: Autoclavable Cassette (Glidewell HTTM Implant Guided Surgical
Kit, Glidewell HTTM Implant Surgical Kit, Glidewell™ Prosthetic Kit)
Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Classification Name: Sterilization Wrap
Regulation Number: 21 CFR 880.6850
Regulatory Class: Class II
Product Code: KCT
III. Predicate Device
Predicate 510(k) #: K180791
Predicate Trade Name: Straumann® BLX Surgical Cassette
Classification Name: Sterilization Wrap
Regulation Number: 21 CFR 880.6850
Regulatory Class: Class II
Product Code: KCT
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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 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.
Device Description IV.
The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface.
Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).
| Device
Model Name | Cassette
Size | Max No. of
Instruments | Weight of
tray empty
(g) | Weight of
tray full
(g) | Vent to
Volume
Ratio |
|----------------------------------------------------|----------------------------|---------------------------|--------------------------------|-------------------------------|-------------------------------------------|
| Glidewell
HT™ Implant
Guided
Surgical Kit | 212mm x
173mm x
64mm | 63 | 484 | 641 | $3.11 X10^{-3}$
(mm-1)
0.079 (in-1) |
| Glidewell
HT™ Implant
Surgical Kit | 199mm x
174mm x
60mm | 52 | 407 | 476 | $6.09 X10^{-4}$
(mm-1)
0.016 (in-1) |
| Glidewell™
Prosthetic Kit | 96mm x
74mm x
60mm | 11 | 163 | 192 | $8.50 X10^{-4}$
(mm-1)
0.022 (in-1) |
The Autoclavable Cassettes will be marketed in the following variations with accompanied instruments:
V. Indications for Use
The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a colorful, prismatic design. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.
to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.
Sterilization parameters:
Pre-vacuum steam: 132°C (270° F) for 4 minutes with 30 minutes drying time.
Sterilization validations for the worst-case Autoclavable Cassette included cassette and instruments. The Autoclavable Cassettes were validated for a maximum load of 641 grams for Glidewell HTM Implant Guided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit, and 192 grams for Glidewell™ Prosthetic Kit.
VI. Technological Comparison
The subject device and predicate device share the following characteristics:
- Same intended use ●
- . Same design
- Same principal of operation .
- Same sterilization method
- Reusable ●
The subject device is technologically different from the predicate device as follows:
- Materials (same materials except medium size cassette which has a lid hinge pin ● made of stainless steel)
- Cassette size/weight ●
- Vent-to-Volume ratio .
- . Drying time
The technological characteristics of the subject device are compared to the predicate device in Table 1 below. Any noted differences in the technological characteristics between the subject device and the predicate device do not raise new concerns of safety and effectiveness.
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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, which is divided into several sections with different colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue.
| Characteristics | Subject Device
(K242564) | Predicate Device
(K180791) | Comparison |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Autoclavable Cassette (Glidewell HTTTM Implant
Guided Surgical Kit, Glidewell HTTTM Implant
Surgical Kit, GlidewellTM Prosthetic Kit) | Straumann® BLX Surgical
Cassette | N/A |
| Manufacturer | Prismatik Dentalcraft, Inc. | Straumann USA, LLC | N/A |
| Regulatory Classification | | | |
| Regulation
Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Classification
Name | Sterilization Wrap | Sterilization Wrap | Same |
| Classification | II | II | Same |
| Product Code | KCT | KCT | Same |
| Intended Use/Indication For Use | | | |
| Intended Use/
Indications for
Use | The Autoclavable Cassettes are
used in healthcare facilities to
organize surgical and prosthetic
instruments during sterilization,
storage, and transport during
and after surgical uses. The
Autoclavable Cassettes are not
intended to maintain sterility;
they are intended to be used in
conjunction with a legally
marketed, validated sterilization
wrap to maintain the sterility of
the enclosed devices.
Sterilization parameters:
Pre-vacuum steam: 132°C
(270° F) for 4 minutes with 30
minutes drying time.
Sterilization validations for the
worst-case Autoclavable
Cassette included cassette and
instruments. The Autoclavable
Cassettes were validated for a
maximum load of 641 grams for
Glidewell HTTM Implant | The Straumann® BLX Cassette
is used in healthcare facilities to
organize, enclose, cleaning,
sterilize, transport, and store
medical devices between
surgical uses. The BLX
Cassette is not intended to
maintain sterility; it is intended
to be used in conjunction with a
legally marketed, validated
sterilization wrap.
The BLX Cassette has been
validated for a maximum load
of 300 grams, including cassette
and instruments.
Sterilization parameters: Pre-
vacuum steam: 132°C (270° F)
for 4 minutes with 20 minutes
drying time. | Same; except
for minor
differences in
the device
trade name,
and device
size/weight. |
| Characteristics | Subject Device
(K242564) | Predicate Device
(K180791) | Comparison |
| Technological Characteristics | | | |
| | Guided Surgical Kit, 476 grams
for Glidewell HT™ Implant
Surgical Kit, and 192 grams for
Glidewell™ Prosthetic Kit. | | |
| Design | Plastic tray and lid | Plastic tray and lid | Same |
| Material | Polyphenylsulfone (Radel
5000)
Silicon
Stainless steel (lid hinge pin for
medium size only) | Polyphenylsulfone (Radel
5000)
Silicon | Same; except
for the medium
size of the
subject device,
which has a lid
hinge pin made
of stainless
steel. |
| Material
Compatible with
Sterilization
Method | Yes | Yes | Same |
| Perforated | Yes; Allow moist heat (steam)
penetration to achieve
sterilization. | Yes; Allow moist heat (steam)
penetration to achieve
sterilization. | Same |
| Enclosed Feature | Silicone grommets | Silicone grommets | Same |
| Reusable | Yes, up to 100x | Yes, up to 100x | Same |
| Sterilization
Method | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Pre-vacuum | Pre-vacuum | Same |
| Parameters | Pre-vacuum:
132°C (270° F) for 4 minutes
with 30 minutes drying time. | Pre-vacuum:
132°C (270° F) for 4 minutes
with 20 minutes drying time. | Similar; more
drying time
required for the
subject device. |
| Sterile barrier | FDA cleared sterilization pouch | FDA cleared sterilization pouch | Same |
| Biocompatibility | The biocompatibility
assessment was performed per
ISO 10993-1 and testing was
performed using methods
described in ISO 10993-5. The
results indicate the subject
devices are non-cytotoxic. | The biocompatibility
assessment was performed per
ISO 10993-1 and testing was
performed using methods
described in ISO 10993-5. The
results indicate the subject
devices are non-cytotoxic. | Same |
Table 1: Comparison Table Between Subject Device and Predicate Device
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Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including pink, red, yellow, green, and blue. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
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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 design. To the right of the triangle is the company name in blue text. The words "PRISMATIK" and "DENTALCRAFT, INC." are stacked on top of each other.
Summary of Non-Clinical Testing VII.
The performance during multiple reprocessing steps for Autoclavable Cassette, recommended in the labeling, was validated according to applicable as recommendations in the FDA guidance document - Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015. The worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio, and worst-case instruments to be contained. The summary of performance testing is provided in Table 2 below.
| Type of Testing | Test Purpose | Acceptance Criteria | Test Result |
|---|---|---|---|
| Manual Cleaning | |||
| Validation | |||
| (ANSI/AAMI | |||
| ST98:2022) | Evaluate and validate | ||
| the manual cleaning of | |||
| the subject device | Visual Inspection: No | ||
| visible soil | |||
| Hemoglobin Test: 70%, which is considered | |||
| non-cytotoxic. | Pass | ||
| Packaging Validation | |||
| (ASTM D4169-23e1) | Packaging performance | ||
| testing | Packaging must withstand | ||
| the distribution | |||
| environment | Pass |
Table 2. Performance Testing Summary
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Image /page/10/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.
VIII. Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, cleared under K180791, Class II (21 CFR 880.6850), product code KCT.