(127 days)
Not Found
No
The summary describes a traditional dental unit and accessories with no mention of AI, ML, image processing, or any related technologies.
No
The device is described as a Dental Operative Unit and Accessories for traditional dental treatment procedures, which are generally considered to be for examination, cleaning, and procedural support rather than direct therapeutic intervention.
No
Explanation: The device is described as a "Dental Operative Unit and Accessories" intended for "traditional and normal patient treatment procedures." Its stated purpose is for treatment, not diagnosis. There is no mention of diagnostic functions or capabilities.
No
The device description explicitly states it is a "Dental Operative Unit and Accessories," which are physical hardware components used in dental procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "traditional and normal patient treatment procedures in the dental operatory." This describes a device used on a patient for treatment, not a device used to examine specimens from a patient outside the body to diagnose or monitor a condition.
- Device Description: The description identifies it as a "Dental Operative Unit and Accessories," which aligns with equipment used for dental procedures directly on a patient.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This dental unit does not fit that description.
N/A
Intended Use / Indications for Use
Dental Unit and Accessories are intended for the Dentists, Hygienists, and Dental Assistants for traditional and normal patient treatment procedures in the dental surgery.
Product codes (comma separated list FDA assigned to the subject device)
NRD
Device Description
Not Found
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
Dentists, Hygienists, and Dental Assistants for traditional and normal patient treatment procedures in the dental surgery.
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): 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
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
SUMMARY
if of Takara Belmont USA; Schiff & Company, West Caldwell, NJ has all of Takara Delinont OUR, Sonin & Ochipany, Prost Calawoli, Ab nad the Chair for diagnosis, treatment and performent and performent on as Chair for dragnosis, troutmont that perfermands of a Shan Prossual Station device is a modification of the existing as nos, Boen for the Dentists, 799. This Dental Ontal Ontal Acoutes and Inormal patient treatment gifts, and Dental accietants for training, and positioning, and positioning of the codures in the dentist only and actight formost of the manufactured for this and accessories over the past twenty five years.
| Dice Detail: | DEC 29 2007 | |
|---|---|---|
| Device Class: | CFR 872.6640 Identified device, Dental | |
| Operative Unit and Accessories as | ||
| Class 1, Reserve. | ||
| Trade or proprietary name: | BELMONT QUOLIS 5000 SERIES | |
| DENTAL UNIT | ||
| Common or usual name: | Dentist's Unit | |
| Classification Name: | Dental Operative Unit and Accessories | |
| Device Listing No.: | 048314 | |
| Classification: | CFR 872.6640 Identified device, Dental | |
| Operative Unit and Accessories, as | ||
| Class 1, Reserve. | ||
| Performance Standards: | IEC 60601-1, ISO-7494-2:2003, | |
| ISO-7494-1:2004, ISO 60601-1 | ||
| Labeling: | Copies are attached. | |
| Fablishment Detail: | ||
| Establishment Registration Number: 96114485 | ||
| TAKARA BELMONT USA, INC. | ||
| BELMONT Equipment Division | ||
| 101 Belmont Drive | ||
| Somerset, New Jersey 08873-1204 |
SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ
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1
performance compliance:
|EC 60601-1, ISO-7494-2:2003, ISO-7494-1-2004, ISO 60601-1
Substantially Equivalent:
This Dental Unit and accessories , based on being "Substantially Equivalent" to the Belmont Dental Unit , Model 2000 series and Model 6000 series, as indicated in the Belmont 510k, Pre-market notification submission dated March 7, 2000, K000799. Comparison of QUOLIS 5000 dental unit and Belmont 2000 Series Dental Unit as presented in attachment 2 indicates that both units are substantially equivalent.
Installation, Operating Instruction, Care and Maintenance are attached.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
DEC 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Takara Belmont USA, Incorporated C/O Robert Schiff, Ph.D., RAC, CQA President Schiff & Company, Incorporated 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re: K072273
Trade/Device Name: Belmont, Dental Unit & Accessories, Quolis 5000 Series Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: NRD Dated: December 14, 2007 Received: December 17, 2007
Dear Dr. Schiff:
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.
3
Page 2 - Dr. Schiff
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 electronic 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 (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Susan Runoe
Chin Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
(K) PREMARKET NOTIFICATION FOR QUOLIS 5000 SERIES DENTAL UNIT TAKARA BELMONT USA, INC.
Indications for Use
510(k) Number (if known):
owice Name: BELMONT, DENTAL UNIT & ACCESSORIES, QUOLIS 5000 ERIES
dications For Use:
ntal Unit and Accessories are intended for the Dentists, Hygienists, and Dental sistants for traditional and normal patient treatment procedures in the dental atory.
iption Use CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruang
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K1572273