(210 days)
Not Found
No
The description mentions "algorithms" for image processing but does not explicitly state or imply the use of AI or ML techniques. The performance studies focus on equivalence to traditional methods and software validation, not on AI/ML performance metrics.
No.
The device is used to record the topographical characteristics of teeth, gingiva, and/or palate for the production of orthodontic appliances and does not directly provide therapy or treatment.
No
The device is an optical impression system that records topographical characteristics of teeth, gingiva, and/or palate for the production of orthodontic appliances. It replaces traditional cast impressions for recording dental features. While it captures data, its intended use and described function do not involve diagnosing a disease, condition, or state of health; rather, it aids in appliance production.
No
The device description explicitly states that the system consists of a handheld wand connected to a computer housed in a base unit, and the wand contains a video camera. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: This device is an intraoral optical impression system. It directly scans the inside of the patient's mouth to create a 3D model. It does not analyze samples taken from the body.
- Intended Use: The intended use is to record the topographical characteristics of teeth, gingiva, and palate for the production of orthodontic appliances. This is a diagnostic tool in the sense of capturing anatomical information, but not in the sense of analyzing biological samples for disease or condition markers.
The device is a medical device, specifically a dental device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.
Product codes (comma separated list FDA assigned to the subject device)
NOF
Device Description
The Digital Impression System for Orthodontic Use (DIS) is a handheld intraoral 3D imager intended for use inside the human oral cavity to digitally capture the three-dimensional topography of teeth, gingiva, and/or palate in clinical settings. It is intended to replace traditional cast impressions which are the current standard for recording dental and orthodontic features of patients undergoing orthodontic treatment. The system is intended to be used by orthodontists and orthodontic assistants in an orthodontic office environment. The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand over the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic manufacturers to design and manufacture customized orthodontic appliances.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Impression System (video camera images)
Anatomical Site
Inside the human oral cavity, teeth, gingiva, palate, upper and lower arches of teeth, left and right bite.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthodontists and orthodontic assistants in an orthodontic office environment. Dental offices, used at dental chair.
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)
Non-Clinical Test Data: Biocompatibility studies (Cytotoxicity, Irritation and Sensitization) have been completed on the disposable wand tip included in the Digital Impression System for Orthodontic Use product. 3D topographical files were created by the Digital Impression System for Orthodontic Use and compared to files derived from, digitized polyvinylsiloxane (PVS) traditional impressions. Test results confirmed that digital impressions generated by the Digital Impression System for Orthodontic Use are substantially equivalent to PVS impressions made by traditional means. Additionally, the Digital Impression System for Orthodontic Use software has been successfully validated to confirm the performance of the device. Clinical Test Data: Clinical testing has not been conducted on this product.
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
§ 872.3661 Optical Impression Systems for CAD/CAM.
(a)
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.(b)
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).
0
510(k) Summary
Image /page/0/Picture/2 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a swooping line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a smaller, sans-serif font.
FEB 8 2013
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared:
February 2013
Device Name:
- Trade Name Digital Impression System for Orthodontic Use .
- Common Name Intraoral Imaging System .
- Classification Name Optical Impression Systems for CAD/CAM, per 21 CFR § 872.3661 .
- Product Codes Optical Impression System, Computer Assisted Design and Manufacturing . (CAD/CAM) of Dental Restorations (NOF)
Devices for Which Substantial Equivalence is Claimed:
- 3M Unitek Lava Chairside Oral Scanner, Brontes Technologies, Inc. K081961 .
Device Description:
The Digital Impression System for Orthodontic Use (DIS) is a handheld intraoral 3D imager intended for use inside the human oral cavity to digitally capture the three-dimensional topography of teeth, gingiva, and/or palate in clinical settings. It is intended to replace traditional cast impressions which are the current standard for recording dental and orthodontic features of patients undergoing orthodontic treatment. The system is intended to be used by orthodontists and orthodontic assistants in an orthodontic office environment. The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator
1717 West Collins Avenue, Orange, CA 92867 800-537-7824. 714-516-7400.
1
moves the wand over the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the sòftware process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic manufacturers to design and manufacture customized orthodontic appliances.
Indications for Use:
The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.
Summary of Technological Characteristics:
The Digital Impression System for Orthodontic Use is substantially equivalent to another legally marketed device in the United States. The Digital Impression System for Orthodontic Use functions in a manner similar to and is intended for the same use as 3M Unitek Lavo Chairside Oral Scanner that is currently marketed by Brontes Technologies, Inc.
| Features | Digital Impression System for
Orthodontic Use | 3M Unitek Lava Chairside Oral
Scanner |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Digital Impression System for
Orthodontic Use is an optical
impression system intended for
use by dental professionals to
record the topographical
characteristics of teeth, gingiva,
and/or palate. The Digital
Impression System is intended for
use in conjunction with the
production of orthodontic
appliances. | The 3M Unitek Lava Chairside Oral
Scanner is an optical impression
system (CAD/CAM) used to record
the topographical characteristics
of teeth. Data generated from the
3M Unitek Lava Chairside Oral
Scanner may be used in
conjunction with the production
of orthodontic appliances,
retainers and accessories. |
| Target users | Dental Professionals trained in
orthodontics | Dental Professionals trained in
orthodontics |
| Where used | Dental offices, used at dental chair | Dental offices, used at dental chair |
| Anatomical Sites | Upper and lower arches of teeth,
left and right bite | Upper and lower arches of teeth,
left and right bite |
| Features | Digital Impression System for
Orthodontic Use | 3M Unitek Lava Chairside Oral
Scanner |
| Technique to | Interferometry measurement of | Stereoscopic measurement of |
2
| Produce 3D Images | video camera images | video camera images |
|---|---|---|
| Light used for illumination | Blue (405 nm) | Blue (405 nm) |
| Light Source | Diode (laser) | Diode (light emitting) |
| Tooth Coating | None | Titanium dioxide powder |
| Components | Handheld imaging wand containing a high accuracy video camera | |
| Computer mounted in housing that can be moved from room to room | ||
| Cable connecting wand with computer | ||
| Touch screen monitor | Handheld imaging wand containing a high accuracy video camera | |
| Computer mounted in housing that can be moved from room to room | ||
| Cable connecting wand with computer | ||
| Touch screen monitor | ||
| Key Characteristics | Handheld wand is moved over the teeth to acquire 3D images | |
| Real-time display of 3D images while patient is being imaged | Handheld wand is moved over the teeth to acquire 3D images | |
| Real-time display of 3D images while patient is being imaged | ||
| Device Output | Output is a software file that can be used as input to CAD/CAM dental processes | Output is a software file that can be used as input to CAD/CAM dental processes |
| Patient Contact Areas | Cheek, tongue, lips, teeth, palate | Cheek, tongue, lips, teeth, palate |
| Patient Contact Areas; Cross-contamination Control | Wand tip is single patient/single use disposable | Wand tip must be sterilized between patients |
| Checks of software and hardware function | Scan of verification target | Scan of verification target |
Non-Clinical Test Data:
Biocompatibility studies (Cytotoxicity, Irritation and Sensitization) have been completed on the disposable wand tip included in the Digital Impression System for Orthodontic Use product.
3D topographical files were created by the Digital Impression System for Orthodontic Use and compared to files derived from, digitized polyvinylsiloxane (PVS) traditional impressions. Test results confirmed that digital impressions generated by the Digital Impression System for Orthodontic Use are substantially equivalent to PVS impressions made by traditional means.
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Additionally, the Digital Impression System for Orthodontic Use software has been successfully validated to confirm the performance of the device.
Clinical Test Data:
Clinical testing has not been conducted on this product.
Conclusion:
Based upon the biocompatibility studies, similar technological characteristics to the predicate device, comparison between 3D topographical files created by the Digital Impression System for Orthodontic Use and files created from digitized PVS impressions and successful validation of the Digital Impression System for Orthodontic Use software, the performance of the Digital Impression System for Orthodontic Use is deemed to be substantially equivalent to 3M Unitek Lava Chairside Oral Scanner.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2013
Ormco Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties. Incorporated 1717 West Collins Avenue ORANGE CA 92867
Re: K122065
Trade/Device Name: Digital Impression System for Orthodontic Use Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: NOF Dated: February 1, 2013 Received: February 5, 2013
Dear Ms. Garman:
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. 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.
5
Page 2 - Ms. Garman
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony De m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KI22065
Indications for Use
510{k} Number (if known):
Device Name: Digital Impression System for Orthodontic Use
Indications For Use:
The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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)
Andrew I. Steen 2013.02.07 15:52:22=05'00'
Division Sianlology, General Hospital
510(k) Number: K122065