(320 days)
No
The description focuses on the mechanical and functional aspects of a dental chair and operative unit, with no mention of AI or ML capabilities.
No
The device is described as a dental chair and operative unit intended to position a patient for visual and manual access to the oral cavity during standard dental procedures, not to treat or diagnose a condition.
No
The device is a dental chair and operative unit designed to position a patient and support dental procedures, not to diagnose medical conditions.
No
The device description clearly outlines a physical dental chair with attached operative units, lights, and other hardware components. It does not describe a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to position a patient for visual and manual access to the oral cavity and support delivery systems for standard dental procedures. This is a physical positioning and support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a dental chair with attached operative units like lights, a cuspidor, and instruments for use within the oral cavity. These are tools for performing dental procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any process that would involve testing something in vitro (outside of the living body).
- Performance Studies: The performance studies listed are related to safety and performance standards for medical devices (electrical safety, biocompatibility, risk management), not validation of diagnostic accuracy.
In summary, the DCI Edge Dental Chair with operative unit is a medical device used for patient positioning and supporting dental procedures within the oral cavity, which is an in vivo (within the living body) activity. It does not perform any diagnostic testing on samples in vitro.
N/A
Intended Use / Indications for Use
The DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manner to provide to the dental practitioner visual and manual access to the oral cavity. This device should provide for the ergonomic necessities of most patients, both adults and children, throughout its range of movement. The device shall also be the means of supporting delivery systems for the purpose of standard dental procedures.
Product codes
KLC, EIA
Device Description
The DCI Edge Chair with Operative Unit is a dental chair with an operative unit attached. There are three main parts to the proposed device: a dental chair, dental light and dental chair has adjustable headrest, backrest, seat height and armrests. The dental chair unit consists of a floor box to which are attached a number of operative units: lights, cuspidor, cup filling device, control panel, and foot control. The instrument panel also includes a 3-way syringe and salvia ejector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
adults and children
Intended User / Care Setting
dental practitioner/dental office or clinic
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6250 Dental chair and accessories.
(a)
Identification. A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.(b)
Classification. Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2016
DCI % Mr. Robert Bellingham Quality & Regulatory Manager 305 N. Springbrook Rd. Newberg, Oregon 97132
Re: K151987
Trade/Device Name: DCI Edge Dental Chair with Operative Unit Regulation Number: 21 CFR 872.6250 Regulation Name: Dental Chair and Accessories Regulatory Class: I Product Code: KLC, EIA Dated: May 2, 2016 Received: May 2, 2016
Dear Mr. Bellingham:
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.
1
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 (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
in filmləri Alinan Alinan Ali Qaran Qırmanın Qaran Qaran Qırmanın Qaran Qırmızı Qaran Qırmızı Qaran Qırmızı Qaran Qırmızı Qaran Qırmızı Qaran Qırmızı Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151987
Device Name
DCI Edge Dental Chair with operative unit
Indications for Use (Describe)
The DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manner to provide to the dental practitioner visual and manual access to the oral cavity. This device should provide for the ergonomic necessities of most patients, both adults and children, throughout its range of movement. The device shall also be the means of supporting delivery systems for the purpose of standard dental procedures.
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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3
305 N. Springbrook Road, Newberg, Oregon, USA 97132
K151987 510(k) Summary DCI Edge Dental Chair with Operative Unit
1 Sponsor
Dental Components Inc. 305 N. Springbrook Road Newberg, Oregon 97128 Telephone: 503-537-2431 Date Prepared: May 31, 2016
2 Device Name
Proprietary Names: DCI Edge Dental Chair with Operative Unit Common/Usual Name: Chair, Dental with Operative Unit Classification: Chair, dental, with operative unit Regulation Number: 21 CFR 872.6250 Class: 1 Product Code: KLC Secondary Product Code: EIA Establishment Registration Number: 3029780
3 Predicate Device
Foshion Chair Mounted Dental Unit (K071353)
4 Intended Use
The DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manner to provide to the dental practitioner visual and manual access to the oral cavity. This device should provide for the ergonomic necessities of most patients, both adults and children, throughout its range of movement. The device shall also be the means of supporting delivery systems for the purpose of standard dental procedures.
5 Device Description and Function
The DCI Edge Chair with Operative Unit is a dental chair with an operative unit attached. There are three main parts to the proposed device: a dental chair, dental light and dental chair has adjustable headrest, backrest, seat height and armrests. The dental chair unit consists of a floor box to which are attached a number of operative units: lights, cuspidor, cup filling device, control panel, and foot control. The instrument panel also includes a 3-way syringe and salvia ejector.
Level of Concern 6
The software was determined to be of a moderate level of concern. The software controls the movement of the dental chair, and it is preprogrammed and activated by the push of a button. The chair then moves slowly up and down, and the backrest moved slowly from an upright or a reclined position. The movement is very slow and the movement is limited by a stop sensor and mechanical hard stop. There are sensors and hard stops to prevent the chair from going beyond its pre-programmed range.
4
7 Technological Characteristics Summary
The technological characteristics between the predicate and proposed device are similar physically and technically. While the wording of the Indications for Use differs, both the subject and predicate devices share the same intended use, as well as equivalent material composition, fundamental scientific technology, principles of operation, and basic design. The predicate device does offer several accessories as standard, such as x-ray viewer and dental handpiece. The DCI Edge chair does not offer these as standard. However, the intended use and the fundamental scientific technology are still the same. The x-ray viewer and dental handpieces are available from other companies as aftermarket devices.
| PARAMETER | DCI EDGE CHAIR
W/OPERATIVE UNIT
(K151987) | DCI DENTAL UNIT
(K944271) | FOSHION DENTAL
CHAIR W/OPERATIVE UNIT (K071353) |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The DCI Edge Dental Chair
with operative unit is a device
intended to position the patient
in such a manner to provide
to the dental practitioner
visual and manual access
to the oral cavity. This device
should provide for the ergonomic
necessities of most patients, both
adults and children, throughout
its range of movement. The
device shall also be the means
of supporting delivery systems
for the purpose of standard
dental procedures. | The DCI Dental Unit is
intended to supply power
and serve as a base for
dental devices and accessories.
The product includes a dental
unit, 3-way syringe and air
foot control. The unit is
intended for use in the
dental office or clinic and is
used by trained dentists
and/or technicians and
assistants. It can be attached
to a chair or stand alone. | The Foshion Chair Mounted
Dental Unit is intended to
supply power and serve as a
base for dental devices and
accessories. The product
includes a dental chair,
operating light x-ray viewer,
control panel, low and high
speed turbine handpieces,
3- way syringe and air foot
control. The unit is intended
for use in the dental office
or clinic and is used by
trained dentists and/or
dental technicians and
assistants. |
| Features | | | |
| Seat and backrest
positioning | Pre-programmed settings. | N/A | Pre-programmed settings. |
| Multiple Handpiece
Automatic Control
System | Three handpiece controls are
standard, up to five handpieces
optional. Handpieces are not
sold with the unit. | Three handpiece controls are
standard, up to five
handpieces optional.
Handpieces are not sold with
the unit. | Three handpiece controls
are standard, up to five
handpiece optional. Unit is
sold with handpieces. |
| Water Control System
for Handpieces and
Syringes | Non-retracting water system for
handpieces and syringes.
Retracting available with check-
valve. | Non-retracting water system
for handpieces and syringes.
Retracting available with
check-valve. | Non-retracting water
system for handpieces and
syringes. Retracting
available with check-valve. |
| 3-Way Syringe | 3-Way syringe with quick
disconnect tip and
autoclavable tips standard. | 3-Way syringe with quick
disconnect tip and
autoclavable tips standard. | 3-Way syringe with quick
disconnect tip and
autoclavable tips
standard. |
| Instrument Holders | Multiple position holder. | Multiple position | Multiple position holder. |
| | | holder. | |
| Assistant Holders | Multiple position holder. | Multiple position | Multiple position holder. |
| | | holder. | |
| Gravity Drain Cuspidor | Cuspidor available. | Cuspidor available. | Cuspidor available. |
| Mounting | Chair and cart. | Chair and cart. | Chair and cart. |
| Vacuum System | HVE and saliva | HVE and saliva ejectors | HVE and saliva ejectors |
| | ejectors available. | available. | available. |
| Foot Control | Standard. | Standard. | Standard. |
| Utility Box with Air and | Standard. | Optional w/Chair | Standard. |
| Water Shut-off, | | | |
| Regulators and Filters | | | |
| Control Pad for | Standard | Optional w/Chair | Standard |
| Chair Movement | | | |
| and Light | | | |
| Heated Water Supply | Available. | Optional w/Chair | Available. |
| Dental Light | Available. | Available | Available. |
| Turbines | Can be added. | Can be added | Standard |
| Upholstery | Standard | Standard if ordered | Standard |
| | | w/Chair | |
| Arm Rest | Standard | Standard if ordered | Standard |
| | | w/Chair | |
| Materials | | | |
| Construction | Metal structural support, | Metal structural support, | Metal structural support, |
| | sheet metal, plastic | sheet metal plastic | sheet metal, plastic covers. |
| | covers. Details contain in | covers. | |
| | product manual. | | |
5
305 N. Springbrook Road, Newberg, Oregon, USA 97132
8 Non Clinical Testing
The DCI Edge Dental Chair with Operative Unit complies with the following performance standards:
- ISO 14971 Second Edition 2007-03-01 Medical devices Application of risk management to medical devices.
- · AAMI ANSI ISO 10993-1:209/(R) 2013 Biological evaluation of medical devices-Part1: Evaluation and testing within a risk management process.
- ANSI/AAMI ES60601-1:2005/(R)2012 Issued: 2012/01/17 Medical Electrical Equipment—Part 1: General requirements for basic safety and essential performance with C1:2009 (R)2012 and A2:2010/(R)2012
- · ISO 60601-1-2:2007 Medical electrical equipment –Part1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and test.
- · IEC 62366 Edition 1.1 Medical devices-Application of usability engineering to medical devices.
- · IEC 80601-2-60:2012 Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipment.
9 Conclusion
DCI, ITL has demonstrated that, for the purposes of FDA's regulation of medical devices, the DCI Edge Dental Chair with Operative Unit is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.