SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020

K974487 · Asi Medical, Inc. · EIA · Feb 18, 1998 · Dental

Device Facts

• Record ID: K974487
• Device Name: SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
• Applicant: Asi Medical, Inc.
• Product Code: EIA · Dental
• Decision Date: Feb 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The SEAC Advanced Dental 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 handpiece connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration.

Device Story

Self-contained dental delivery system; includes air compressor, vacuum system, and water supply. Operates dental handpieces and suction instruments. Optional integration of Micadent air abrasion system for intra-oral procedures (etching, surface preparation for composite restoration). Used in clinical dental settings; operated by dental professionals. Device provides power and utility connections for handpieces and suction tools; Micadent component functions as an air-abrasion accessory. Benefits include portability and consolidated dental utility support.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and functional similarity to predicate devices.

Technological Characteristics

Self-contained mobile dental unit; includes air compressor, vacuum system, and water supply. Integrates air-abrasion handpiece via internal air line connection. Class I device.

Indications for Use

Indicated for use as a self-contained dental delivery system to operate dental handpieces and suction instruments, and for intra-oral air abrasion procedures including etching and surface preparation for composite restorations.

Regulatory Classification

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.

Predicate Devices

• SEAC Mobile Dental System (K932873)
• K964

Reference Devices

• Micadent air abrasion system

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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

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

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 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 Regulations, 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 Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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

{1}

Page 2 - Mr. McPeek

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

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 [phone] or [phone] 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}

DEC-04-1997 12:36 766*3559 303 766 3559 P.02

Page 1 of 1

510(k) Number (if known): Applied 11/24/97 Existing 510 K#s K932873 and K964

Device Name: Mobile Self-Contacted Dental Unit

Indications For Use:

Indications For Use:

The SEAC Advanced Dental 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 handpiece connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration.

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 Medidents 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Renner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices 11/15/97
510(k) Number 104

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)

DEC-02-1997 12:03 301 480 3002 96% P.02