Who is the manufacturer of FINECUBE DENTAL CT?

The Yoshida Dental Mfg. Co., Ltd. filed the 510(k) submission for FINECUBE DENTAL CT (K063622).

What is the FDA product code for FINECUBE DENTAL CT?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for FINECUBE DENTAL CT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for FINECUBE DENTAL CT?

DVT SCANNER (K051980); 3D Accu-I-tomo XYZ Slice View Tomograph (K030450).

Who can help prepare an FDA 510(k) submission like FINECUBE DENTAL CT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FINECUBE DENTAL CT

K063622 · The Yoshida Dental Mfg. Co., Ltd. · OAS · Feb 8, 2007 · Radiology

Device Facts

Record ID	K063622
Device Name	FINECUBE DENTAL CT
Applicant	The Yoshida Dental Mfg. Co., Ltd.
Product Code	OAS · Radiology
Decision Date	Feb 8, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2

Intended Use

FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Device Story

FineCube is a cone beam computed tomography (CBCT) system for head and neck imaging. It captures a 360-degree rotational X-ray sequence using a flat panel sensor (608 x 616 pixel matrix, 200 μm resolution). The system constructs a 3D model from the acquired rotational images. Operated by physicians, dentists, or X-ray technologists in clinical settings, the device provides 3D information for high-contrast objects. Healthcare providers use the 3D output to support diagnostic decision-making in dentomaxillofacial and ENT applications.

Clinical Evidence

Bench testing, laboratory testing, and user testing were performed. No specific clinical trial data or performance metrics (sensitivity/specificity) were provided in the summary; the manufacturer concluded the device is as safe and effective as the predicate devices based on these evaluations.

Technological Characteristics

Cone beam computed tomography (CBCT) system. X-ray generation/acquisition system with flat panel sensor. Focal spot: 0.2mm x 0.2mm. Tube voltage: 90kV; Tube current: 4mA. Exposure time: 19/37 seconds. Image matrix: 608 x 616 pixels; Pixel size: 200μm. Power: AC120V, 60Hz. Emergency stop switch included.

Indications for Use

Indicated for diagnostic support via cone beam CT imaging of head, neck, ENT, and dentomaxillofacial areas. Intended for use by physicians, dentists, and x-ray technologists.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

DVT SCANNER (K051980)
3D Accu-I-tomo XYZ Slice View Tomograph (K030450)

Related Devices

K073695 — 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 · J. Morita USA, Inc. · Apr 9, 2008
K130442 — NEWTOM VGI AND NEWTOM 5G · Qr S.R.L. · Jul 3, 2013
K190856 — SeeFactorCT3 · Epica International, Inc. · Sep 20, 2019
K130297 — SCANORA 3DX · Palodex Group OY · May 29, 2013
K053046 — ILUMA ORTHOCAT/DENTALCAT · Imtec Corp. · Nov 8, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ K063622 8 2007 FEB ### 510(k) Summary 510(k) Number The Yoshida Dental Mfg. Co., Ltd. 1-3-6, Kotobashi, Sumida-Ku Tokyo, JAPAN 130 85164 Tel: 81-3-3631-2165 Fax: 81-3-3633-9427 www.yoshida-net.co.jp Date Prepared: November 30, 2006 R&D Department (テクニカルセンタ) Contact: Hidenori Watanabe(渡辺英憲) - l . Identification of the Device: Proprietary-Trade Name: FineCube Classification Name: Computed Tomography X-Ray System Product Code 90 JAK Common/Usual Name: Dental CT - 2. Equivalent legally marketed device: Imaging Sciences International Inc. DVT SCANNER K051980; J. Morita Manufacturing. Corporation. 3D Accu-I-tomo XYZ Slice View Tomograph K030450 - 3. Indications for Use (intended use) FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.. - 4. Description of the Device: The FineCube consists of two main elements: (1) The X-Ray generation and acquisition system and (2) the image analysis software. The X-Ray generation/acquisition system creates a cone-shaped x-ray field which is acquired on a flat panel sensor with a resolution of 608 x 616 x 200 um. FineCube is an X-ray imaging device that constructs a three dimensional model from images taken during a rotational X-ray sequence. FineCube is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects - 5. Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices. | Manufacturer | Imaging Sciences International Inc. K051980 | J. Morita Manufacturing. Corporation. K030450 | Yoshida Dental | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | DVT SCANNER | 3D Accu-l-tomo XYZ Slice View Tomograph | FineCube | | Manufacturer | Imaging Sciences | J. Morita | Yoshida Dental | | | International Inc. | Manufacturing. | | | | K051980 | Corporation. | | | | | K030450 | | | Indication for use | The DVT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The DVT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The DVT Scanner is optimized for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, temporal bone, etc. | The 3D Accu-1-tom0 is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two- dimensional views of this volume, displaying both two- and three dimensional images. The device can also be used for fluoroscopy during surgery, mostly for ENT and TMJ applications and mostly with a contrast medium. The device is operated and used by physicians, dentists, and x- ray technologists. | FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists. | | Specification comparison | Focal spot: 0.6mm Tube voltage: 60,80,100,120kV Tube current: 10,15mA Exposure time: 9.6sec Emergency stop method: Emergency stop switch Input: 10kVA Power supply: AC200V Projection mode: CT Detector dimension: 9.7 / 4.5 inch | Focal spot: 0.5mm x 0.5mm Tube voltage: 60 ~ 90kV Tube current: 1 ~ 10mA Exposure time: Under 18sec Emergency stop method: Emergency stop switch Input: 2.0kVA Power supply: AC100V , 50/60Hz Projection mode: CT, Panoramic Detector dimension: 109mm x 111mm | Focal spot: 0.2mm×0.2mm Tube voltage: 90kV Tube current: 4mA Exposure time: 19 / 37sec Emergency stop method: Emergency stop switch Input: 1.5kVA Power supply: AC120V , 60Hz Projection mode: CT Detector dimension: 120mm x 120mm Pixel size: 200μm×200μm Image matrix size: 608 × 616 pixels | ### 6. Substantial Equivalence Chart {1}------------------------------------------------ #### 7. . Conclusion After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Yoshida Dental that the FineCube Dental CT System is appare and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is centered on the page. There is a logo to the left of the text. The logo is a stylized image of a human figure. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 The Yoshida Dental Mfg., Co., Ltd. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015 ## 8 2007 Re: K063622 Trade/Device Name: FineCube Dental CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: December 1, 2006 Received: December 20, 2006 Dear Mr. Kamm: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. Image /page/2/Picture/9 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo in a stylized font. The word "Centennial" is below the letters. There are three stars below the word "Centennial." *Protecting and Promoting Public Health* {3}------------------------------------------------ Page 2 - 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: regirstration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the sectoric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-0150, This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(x) marketed predicate device results in a classification for your device and thus, perceits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours. Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K063/22 Device Name: FineCube Dental CT System Indications For Use: FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (Please do Not WRITE BELOW THIS LINE-CONTINUE on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number Page 1 of 1