(147 days)
Not Found
No
The description focuses on mechanical and fluid control systems for dental instruments, with no mention of AI or ML terms, image processing, or data-driven performance metrics.
No.
The device functions as an interface to connect dental hand instruments to utilities and manage their operation, rather than directly treating a patient itself. It is a system management device for a dental operatory.
No
Explanation: The device description states its function is to provide an interface and system management for dental operative hand instruments, supplying utilities like air and water. It does not mention any diagnostic capabilities such as capturing, analyzing, or interpreting patient data for illness detection or diagnosis.
No
The device description clearly outlines a physical dental operative unit with hardware components like controls for air pressure and water flow, connections for utilities (air, water, suction, drain, electricity), and a stackable design for tools and accessories. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "effective treatment of patients" by "Dental Professionals." This describes a device used directly on or with a patient for treatment, not for testing samples outside the body.
- Device Description: The description details a "Dental Operative Unit" that connects dental instruments to utilities like air, water, and electricity. It manages the operation of hand instruments. This is consistent with a device used in a dental operatory for procedures, not for diagnostic testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This dental delivery system does not fit that description.
N/A
Intended Use / Indications for Use
The Boyd Delivery Unit is intended to supply utilities to and serve as a base for dental tools and accessories. The use of this device does not differ significantly from the predicate dental operative units.
Boyd delivery systems are intended for use by Dental Professionals for effective treatment of patients.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
The Boyd Delivery Unit is a Dental Operative Unit that provides the dentist with primary requirements for a dental operatory. The delivery system is designed to be used as an interface device to connect the dental operatory hand instruments to the appropriate supply utility such as air, water suction, drain and electricity. It functions as a system management device that provides a method of operating various hand instruments from a single control input device. The unit is furnished with controls that allow the dentist or operator to set the air pressure and water flow to the hand pieces and the syringe in the delivery head. The unit is of a stackable design providing a base for dental tools and accessories. Assistant's instrumentation delivery system, water heater, and the cuspidor are all features that this unit can offer.
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
Dental Professionals
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
510(k) SUMMARY
-
- Boyd Industries, Inc. 12900 44th Street North Clearwater, FL 33762 US Phone: 727-561-9292 Fax: 727-561-9393 Contact: Bruce Livingston Establishment Registration Number: 1062917 (reference next page) Date of Submission: March 8, 2002
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- Trade Name: Boyd Delivery Units Common Name: Delivery System Classification Name: Dental Operative Unit and Accessories
-
- Equivalent Device:
The Boyd Delivery Unit is substantial to similar Dental Operative Unit and Accessories previously cleared with the FDA for marketing in the United States, using the same basic technology, design process and attention to safety. Copies of product literature are included in Section 1 and Comparison Data is included in section 2 of this submittal.
-
- Technical Description:
The Boyd Delivery Unit is a Dental Operative Unit that provides the dentist with primary requirements for a dental operatory. The delivery system is designed to be used as an interface device to connect the dental operatory hand instruments to the appropriate supply utility such as air, water suction, drain and electricity. It functions as a system management device that provides a method of operating various hand instruments from a single control input device. The unit is furnished with controls that allow the dentist or operator to set the air pressure and water flow to the hand pieces and the syringe in the delivery head. The unit is of a stackable design providing a base for dental tools and accessories. Assistant's instrumentation delivery system, water heater, and the cuspidor are all features that this unit can offer.
- Technical Description:
-
- Intended use. The Boyd Delivery Unit is intended to supply utilities to and serve as a base for dental tools and accessories. The use of this device does not differ significantly from the predicate dental operative units.
6) Comparison of device to marketed devices
Reference chart "Comparison of device to marketed devices" on the following page.
1
isting from FDA Websit Ticial Correspondent Name: MR. BRUCE LIVING:
Toial Correspondent Phone: Number: 727-561-929
Torial Correspondent Phone: Number: 727-561-9299
000-44TH STREET, INC.
EARWATER, F Setablishment Names
2900 44TA STREET NYON
2017 ATTA STREET NYON
CLEAR ANTAL STREET NYONE Nomber: 10629 17
Stablishment Operationa: Commont Manufactu
Sate of Rugustionar: Cont Owner/Operator:
BOYD INDUSTRUES, INC.
I2900 44TH STRIEST NORTH
CLEARWATERS FLE 33722
CLEARWATERS, FL 33722
Owner/Operator Number: 90303
omparison of device to marketed device
Feature | Boyd Industries, Inc. | a-dec (K000966) | DentalEZ (K931204) | Marus Dental |
---|---|---|---|---|
Mounting unit | Cabinet | Cabinet | Cabinet | Cabinet |
Instruments | ||||
Available | High-speed handpiece hookup, low | |||
speed handpiece hookup, 3-way | ||||
syringe, saliva ejector, high volume | ||||
evacuation with solids collector | High-speed handpiece hookup, low | |||
speed handpiece hookup, 3-way | ||||
syringe, saliva ejector, high volume | ||||
evacuation with solids collector | High-speed handpiece hookup, low | |||
speed handpiece hookup, 3-way | ||||
syringe, saliva ejector, high volume | ||||
evacuation with solids collector | High-speed handpiece hookup, low | |||
speed handpiece hookup, 3-way | ||||
syringe, saliva ejector, high volume. | ||||
Activation | Master off/on valve, handpiece | |||
toggle switch and foot control | handpiece toggle switch and foot | |||
control | Master off/on valve, handpiece | |||
toggle switch and foot control | Automatic activation for each | |||
handpiece | ||||
Cleaning | Air flush system | Water flush | Water flush | Water flush |
Water System | Self contained | Self contained | City hook up or self contained | City hook up |
2
Image /page/2/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 three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 8 2002
Mr. Bruce Livingston Boyd Industries, Incorporated 12900 44th Street North Clearwater, Florida 33762
Re: K020833
Trade/Device Name: Boyd Delivery Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: June 14, 2002 Received: June 27, 2002
Dear Mr. Livingston:
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.
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.
3
Page 2 - Livingston
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Ulatsowski
A. Ulatowski Timot Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
33
Pege. ........................................................................................................................................................................
510(k) Number (if known)
Device Name:
Indications For Use:
.
Boyd delivery systems are intended for use by Dental Professionals for effective treatment of patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODF)
Prescription Usey (Per 21 CFR 801,109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Swar Rumpie
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Oractrol Devices Division of Anesthesionsy, Dental Devices
510(k) Number. K020833