CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US

K072643 · Olympus Corporation · KZN · Nov 16, 2007 · Dental

Device Facts

• Record ID: K072643
• Device Name: CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
• Applicant: Olympus Corporation
• Product Code: KZN · Dental
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3661
• Device Class: Class 2

Indications for Use

The Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US is intended for use in automated color shade-matching to assist in dental restoration. The targeted teeth for color analysis are the left and right central incisors, lateral incisors and canines.

Device Story

Crystaleye Spectrophotometer is an automated color shade-matching system for dental restorations. Device components include a spectrophotometer, cradle, contact cap, and required PC software. Operation involves capturing an image of a target tooth (central/lateral incisors or canines) using the spectrophotometer; software compares captured color data against a pre-loaded digital database of reference tooth shades from multiple manufacturers. Output is the closest matching shade from the database, displayed to the clinician. Used in dental clinics by dental or medical personnel to replace manual shade-matching processes. The system assists clinicians in selecting appropriate restoration colors, potentially improving accuracy and efficiency in dental aesthetic procedures.

Clinical Evidence

No clinical data. Bench testing only. 225 evaluations performed using 5 shades from 5 manufacturers, measured at 3 points each, across 3 test iterations. The device achieved 100% accuracy in identifying the correct manufacturer shade from its database.

Technological Characteristics

Spectrophotometer-based optical impression system. Components: spectrophotometer, cradle, contact cap, USB/AC cables, PC software. Connectivity: USB to PC. Software-based matching against a digital database of reference tooth shades. No specific material standards or energy types beyond standard electrical operation mentioned.

Indications for Use

Indicated for automated color shade-matching of left and right central incisors, lateral incisors, and canines to assist in dental restoration.

Regulatory Classification

Identification

An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.

Special Controls

*Classification.* Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).

Predicate Devices

• VITAPAN CLASSICAL Shade Guide
• VITA SYSTEM 3D-MASTER Tooth Guide
• IVOCLAR VIVADENT CHROMASCOP
• NORITAKE Shade Guide
• VINTAGE HALO NCC

Submission Summary (Full Text)

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| | K072643 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | |
| Owner/Submitter: | OLYMPUS CORPORATION<br>Corporate R&D Center<br>2-3 Kuboyama-cho, Hachioji-shi<br>NOV 1 6 2007<br>Tokyo, 192-8512, Japan |
| | Telephone: [phone]<br>Facsimile: 011-81-426-91-7350<br>Contact: Etsuya Sawada<br>Title: Manager, Quality Assurance and<br>Regulatory Affairs<br>Date of Preparation: September 10, 2007 |
| Device Trade Name: | "Crystaleye Spectrophotometer/<br>Crystaleye Basic Set CE100-DC/US"<br>("Crystaleye Device") |
| Common Name: | Scanner, Color |
| Classification Name: | Optical Impression Systems for CAD/CAM<br>(21 C.F.R. §872.3661) |

- Legally Marketed Device for which equivalence is claimed:
The predicate devices for the Crystaleye Device are the multiple shade guides and shade teeth sets for manual color evaluation and matching, including the following: VITAPAN CLASSICAL Shade Guide, VITA SYSTEM 3D-MASTER Tooth Guide, IVOCLAR VIVADENT CHROMASCOP, NORITAKE Shade Guide, and VINTAGE HALO NCC. The Crystaleye Device utilizes the tooth shades from these shade guides in its shade-matching database.

## Description of Device:

The Crystaleye Device is an automated color shade-matching device, based upon a database of reference tooth shades. The Crystaleye Device is comprised of the following components: Spectrophotometer, AC Adapter, Cradle, Contact Cap (5 pcs.), AC Cable, USB Cable, Master CDs, and Instructions. A personal computer is also required to run the Master CDs. The reference color tooth shades of multiple dental restoration manufacturers are loaded into the computer. The spectrophotometer captures an image of the target tooth, and the software matches a patient's color tooth shade with the closest available shade in the computerized reference database.

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## Intended Use of Device:

The Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US is intended for use in automated color shade-matching to assist in dental restoration. The targeted teeth for color analysis are the left and right central incisors, lateral incisors and canines.

## Summary of Technological Characteristics Compared to Predicate Devices:

The Crystaleye Device utilizes the reference tooth shades of multiple dental restoration manufacturers, which are the predicate devices. Currently, use of the predicate devices requires the manual comparison of multiple tooth shades to a patient's individualized tooth shade to achieve the closest match. The Crystaleye Device automates that matching function through use of a Spectrophotometer and a computerized database of the tooth shades available from each manufacturer. The dental or medical personnel can then visually evaluate the "match" identified by the Crystaleye Device.

#### Discussion of Non-Clinical Tests:

Bench testing was conducted on the Crystaleye Device. Five tooth color shades (with three measurement points each) were randomly selected from each of the five sets of reference shades from multiple dental restoration device manufacturers. The Crystaleye Device was then tested three times for each set of manufacturer shades to determine if the device correctly identified the same manufacturer shade from its database of tooth shades available from each manufacturer. Thus, the Crystaleve Device was subjected to 225 test evaluations, i.e. 5 shades per set x 3 measurement points per shade x 5 sets x 3 tests. The Crystaleye Device correctly identified the color shade for each of the 225 test evaluations.

#### Assessment of Clinical Performance Data:

:

The Premarket Notification does not rely upon any clinical performance data. A summary of a presentation on clinical usage and experience is included as Ref. 1 S. Ishikawa-Nagai, et al., "Summary of Presentations Made at (Attachment 9). American Association of Dental Research 2006 and International Association of Dental Research 2006 and Clinical Cases from Ongoing Study" (2007).

## Conclusions Drawn from Non-Clinical Tests:

The Crystaleye Device provides a color match identification which medical and dental personnel may visually evaluate quickly without manually attempting to match multiple color shades. The Crystaleye Device substantially improves the ease and accuracy of color shade-matching of teeth for dental restoration.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2007

Olympus Corporation C/O Fumiaki Kanai, Ph.D. President and Chief Executive Officer MIC International 4-2-1 Yushima, Bunkyo-ku Tokyo, 113-0034 JAPAN

Re: K072643

Trade/Device Name: Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: KZN Dated: September 18, 2007 Received: September 18, 2007

Dear Dr. Kanai:

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 (PMA), 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.

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#### Page 2 - Dr. Kanai

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 a legally marketed predicate device results in a classification for your device and thus, permits 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nuhrhpdgl
Chiu Lin, Ph.D. for

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

1207 2643 510(k) Number (if known):

Device Name: "Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US"

Indications for Use:

The Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US is intended for use in automated color shade-matching to assist in dental restoration. The targeted teeth for color analysis are the left and right central incisors, lateral incisors and canines.

| Prescription Use | |
|-----------------------------|----|
| (Part 21 CFR 801 Subpart D) | or |

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Runser

(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. k072643