SIMPLEX AIRBRATOR (SAB-7)

K980672 · Irt Management Corp. · KOJ · May 4, 2000 · Dental

Device Facts

• Record ID: K980672
• Device Name: SIMPLEX AIRBRATOR (SAB-7)
• Applicant: Irt Management Corp.
• Product Code: KOJ · Dental
• Decision Date: May 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cleaning of Tooth Surfaces Stain Removal from Tooth Surfaces Removal of Surface Deposits from Toeth Cleaning of Dental Pits and Fissures Cleaning of Dental I its and Fissures Microciching of enamel and dentin surfaces in preparation for adhesive bonding procedures Microciding of enamer and deching and etching) of metallic, ceramic, composite and actylic surfaces for dental procedures including bonding, cementation, repair and restoration Delivers a controlled stream of particles for the removal of tooth structure Specific Dental Usage: Preparation of tooth surfaces for sealants Preparation of tooth surfaces for orthodontic bracket bonding Preparation of tooth surfaces for bonding bridges Preparation of internal root surfaces for post procedures (after root canal therapy) I reparation of tooth surfaces for adhesive bonding procedures, ceramic inlays, crowns and bridges Preparation of root surfaces for periodontal procedures Repair of composite, acrylic and ceramic restorations Occlusal adjustments and equilibration Repair of prosthetic appliances Bonded splint procedures Removal of cement from temporary and permanent procedures Class I-V cavity preparation NOT FOR USE ON AMALGAM

Device Story

The Simplex Airbrator is a dental device that delivers a controlled stream of abrasive particles to tooth and restorative surfaces. It is used by dental professionals in a clinical setting to clean, remove stains/deposits, and micro-etch surfaces to prepare them for adhesive bonding, cementation, or repair. The device functions as an air-abrasion system, where the high-velocity particle stream mechanically abrades the target surface. This process facilitates clinical procedures such as sealant placement, orthodontic bracket bonding, cavity preparation, and prosthetic repair. By providing a precise method for surface preparation, the device enhances the efficacy of adhesive bonding and restorative dental treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air-abrasion system; delivers controlled particle stream for mechanical surface modification. Designed for dental use on enamel, dentin, metallic, ceramic, composite, and acrylic surfaces. Not for use on amalgam.

Indications for Use

Indicated for dental patients requiring surface cleaning, stain removal, deposit removal, pit/fissure cleaning, and micro-etching of enamel, dentin, metallic, ceramic, composite, or acrylic surfaces for bonding, restoration, or periodontal procedures. Contraindicated for use on amalgam.

Regulatory Classification

Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2000

Nicholas G. Levandoski, Ph.D. President IRT Management Corporation 470 Ansin Boulevard, Suite G Hallandale, Florida 33009

Re : K980672 BioStar Airbrator Trade Name: Regulatory Class: II Product Code: KOJ Dated: February 18, 1998 Received: February 20, 1998

Dear Dr. Levandoski:

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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 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 through 542 of

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Page 2 - Dr. Levandoski

the Act for devices under the Electronic Product Radiation the Act for devices andor end rederal laws or regulations.

This letter will allow you to begin marketing your device as first it do will be market notification. The FDA described in your siet... puivalence of your device to a legally Finding of subbeaneral ogaresults in a classification for your marketed predicate device robates as a see as the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulacion (21 crx rares), please contact the Office of Vicio diagnobero ac [phone]. Additionally, for questions on Compilance at (501) 591 ising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be Information on your rision of Small Manufacturers Assistance obcained from the biving [phone] or [phone] or at at Its coll-free namber (000)- 050 - 05 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

Sincerely yours,

Timothy Ulatowski

atowski 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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Pagc _1_ of __ l

510(k) Number (if known): K980672

Device Name: SIMPLEXTM AIRBRATORTM

Indications For Use:

## General Usage:

Cleaning of Tooth Surfaces Stain Removal from Tooth Surfaces Removal of Surface Deposits from Toeth Cleaning of Dental Pits and Fissures Cleaning of Dental I its and Fissures
Microciching of enamel and dentin surfaces in preparation for adhesive bonding procedures Microciding of enamer and deching and etching) of metallic, ceramic, composite and actylic surfaces for dental procedures including bonding, cementation, repair and restoration Delivers a controlled stream of particles for the removal of tooth structure

Specific Dental Usage: Preparation of tooth surfaces for sealants Preparation of tooth surfaces for orthodontic bracket bonding Preparation of tooth surfaces for bonding bridges Preparation of internal root surfaces for post procedures (after root canal therapy) I reparation of tooth surfaces for adhesive bonding procedures, ceramic inlays, crowns and bridges Preparation of root surfaces for periodontal procedures Repair of composite, acrylic and ceramic restorations Occlusal adjustments and equilibration Repair of prosthetic appliances Bonded splint procedures Removal of cement from temporary and permanent procedures Class I-V cavity preparation

NOT FOR USE ON AMALGAM

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K980672 |

| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|---|
|---------------------------------------|---|

OR

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