SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 by ASI MEDICAL, INC.

The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,

Device Description

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) letter does not contain the information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a clearance letter for a "Seac Advanced Dental System" (Model 2001 or 2020), indicating that the device has been found substantially equivalent to a predicate device. It confirms that the device can be marketed.

However, it does not include:

A table of acceptance criteria and reported device performance: This type of information would be found in the premarket submission itself, detailing the performance standards the manufacturer set for their device and the results of their testing.
Sample size used for the test set and data provenance: Again, this data is part of the studies submitted, not typically in the clearance letter.
Number of experts and their qualifications for ground truth: This would be part of the study design and methodology.
Adjudication method: Similar to the above, this is a detail of the study design.
Multi-reader multi-case (MRMC) comparative effectiveness study details: This type of study is not mentioned or described in the provided text.
Standalone (algorithm only) performance: This device is a physical dental system, not an algorithm, so this criterion is not applicable.
Type of ground truth used: Not explicitly stated.
Training set sample size and ground truth establishment for training set: Not applicable as it's a physical device and not an AI/ML algorithm that requires training data in the same way.

The document primarily focuses on the regulatory clearance process and the determination of substantial equivalence, based on the device's design, function, and indications for use, rather than detailed performance study results.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or progress. The profiles are arranged in a way that they appear to be connected or overlapping. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1998

Mr. John W. McPeek President ASI Medical, Incorporated 14550 East Easter Avenue, Suite 1000 Englewood, Colorado 80112

Re : K974487 Seac Advanced Dental System - Model 2001, Trade Name: 2010 or Model 2020 Requlatory Class: I Product Code: EIA November 24, 1997 Dated: November 26, 1997 Received:

Dear Mr. McPeek:

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 redical bevest 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895 ... A ... ................... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. McPeek

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 ene regaracion onetiisation" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division 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

Timo A IIIatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Labels	Values
510(k) Number (if known):	Applied 11/24/97 Existing 510 K's K932873 and K964
Device Name:	Mobile Self-Contained Dental Unit
Indications For Use:

Indications For Use:

DEC-

The SEAC Advanced Dental System is substantially similar in design and function as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidenta and will be supplied to ASI as a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation,

(PLRASE DO NOT WELTE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERIDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
	Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K944418 7

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use (Optional Format 1-2-96)
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02-12-1997 12:03	301 496 3002	96% P.02
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Regulation Number and Section

§ 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.