(43 days)
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Not Found
No
The summary describes a standard dental unit with basic automatic controls, not mentioning any AI/ML features or data processing capabilities.
No
The device serves as a base and power supply for other dental services and does not directly provide therapeutic treatment.
No
The device description states it is intended to "supply power to and serve as a base for other dental services," and lists components commonly found in a dental chair unit. There is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device description explicitly lists multiple hardware components (automatic control system, water control, syringe, instrument holder, vacuum system, foot control, utility box), indicating it is not software-only.
Based on the provided information, the LSM Dental Unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to supply power to and serve as a base for other dental services." This describes a piece of equipment used in a clinical setting to support dental procedures, not a device used to examine specimens from the human body in vitro (outside the body) to provide diagnostic information.
- Device Description: The description lists components like hand pieces, syringes, vacuum systems, etc., which are all tools used directly on a patient during dental treatment. None of these components are designed for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the LSM Dental Unit is a piece of dental equipment used for patient treatment, not an IVD.
N/A
Intended Use / Indications for Use
The LSM Dental Unit is intended to supply power to and serve as a base for other dental services. The Dental Operative Unit includes an automatic control system, a water control for hand pieces and syringes, a 3 way syringe, instrument holder, mounting, vacuum system, foot control and utility box.
Product codes
EIA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular border with text and an abstract symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circular border. The central symbol is an abstract representation of a human figure, with three stylized lines forming the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1999
Mr. David R. Cole General Manager Lite Specialty Metal Works, Incorporated 20460 S.W. Avery Court Tualatin, Orlando 97062
Re : K984609 ADEC Dental Unit, Models Century Plus & Trade Name: Cascade, DCI Dental Unit Regulatory Class: I Product Code: EIA Dated: December 4, 1998 December 28, 1998 Received:
Dear Mr. Cole:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Cole
This letter will allow you to begin marketing your device as described in your 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 marice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 the regaracion chercious (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your vision of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
LITE SPECIALTY
Image /page/2/Picture/2 description: The image shows a series of numbers in a bold, sans-serif font. The numbers are K984609 and they appear to be part of a larger document or label. The numbers are large and take up most of the frame, making them easily readable. The top right corner of the image says "PAGE 52".
Image /page/2/Picture/3 description: The image shows the logo for Lite Specialty Metal Works, Inc. The logo consists of the letters "LSM" stacked on top of each other inside of a black polygon on the left side of the image. The words "WORKS" are below the letters "LSM". On the right side of the image, the words "LITE SPECIALTY METAL WORKS, INC." are written in bold black letters.
510 (K) NUMBER: K984609
DEVICE NAME: LSM DENTAL UNIT
INDICATIONS FOR USE:
The LSM Dental Unit is intended to supply power to and serve as a base for other dental services. The Dental Operative Unit includes an automatic control system, a water control for hand pieces and syringes, a 3 way syringe, instrument holder, mounting, vacuum system, foot control and utility box.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-The-Counter-Use
Susan Runner
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Page 50 (Rev. 1)