ACCU-PREP

K970484 · Bisco, Inc. · KOJ · Jul 1, 1997 · Dental

Device Facts

• Record ID: K970484
• Device Name: ACCU-PREP
• Applicant: Bisco, Inc.
• Product Code: KOJ · Dental
• Decision Date: Jul 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2

Intended Use

ACCU-PREP is intended to be used to abrade and enhance the bond between the prepared tooth and cast dental metals for Maryland bridges, for cementation of cast metal restorations, for porcelain repair, as a porcelain etch substitute, to prepare indirect composite restorations for cementation, for repair of composite or resin restorations, repair of acrylic facings on cast restorations, endodontic post preparation, denture repairs, and orthodontic applications such as: preparation of brackets to enhance bonding, cement removal from brackets, and enhancement of adhesion to tooth structure.

Device Story

ACCU-PREP is a handheld, compressed-air-driven dental sandblasting instrument. It utilizes a venturi principle to draw abrasive powder (typically 50μm aluminum oxide) from an internal reservoir and propel it at high velocity toward dental hard tissues or restorative materials. The device is operated by dental professionals in a clinical setting. By roughening surfaces, it enhances micromechanical bonding for various dental procedures, including bridge cementation, porcelain/composite repairs, and orthodontic bracket preparation. The device functions similarly to a perfume atomizer, where air flow creates a vacuum to entrain abrasive particles. Compared to the predicate, the device offers improved aesthetics, a more ergonomic reservoir placement (Type II), and operates at a lower minimum air pressure (40 psig). The output is a stream of abrasive particles used to clean or abrade surfaces, facilitating stronger adhesion of dental materials and improving clinical outcomes for restorative and orthodontic treatments.

Clinical Evidence

Bench testing only. Performance compared to predicate using shear bond strength tests on human extracted teeth and Scanning Electron Microscopy (SEM) of abraded surfaces. Results showed no statistically significant difference in bond strength (p ≥ 0.05) and virtually identical surface abrasion patterns.

Technological Characteristics

Handheld dental sandblasting instrument; compressed air energy source (40-100 psig); venturi-based abrasive delivery; uses 50μm aluminum oxide (range 0.05-90μm); Type II model is fully autoclavable; mechanical operation; no software or electronic components.

Indications for Use

Indicated for dental professionals performing restorative, endodontic, and orthodontic procedures requiring surface abrasion to enhance bonding. Applications include Maryland bridges, cast metal restoration cementation, porcelain repair, porcelain etching, composite/polymeric restoration repair, acrylic facing repair, endodontic post preparation, denture repair, and orthodontic bracket bonding/cleaning.

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.”

Predicate Devices

• MICROETCHER™

Submission Summary (Full Text)

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BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143
510(k) submission for ACCU-PREP™
JUL 1 1997
K970484
30

# 510(k) SUMMARY
As Required by the Safe Medical Devices Act of 1990

# IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

## PREDICATE DEVICE
### MICROETCHER™

MICROETCHER is a compressed air driven dental sandblasting device intended for intra-oral use to roughen dental hard tissues or restorative materials to enhance bonding of resin materials. The device is a hand held instrument resembling a dental handpiece in shape and function. The unit is operated at 60-100 psig of compressed air. A venturi principle forces an abrasive, aluminum oxide (50μm particle size), toward the object to be abraded. The high velocity abrasive imparts sufficient energy to abrade and remove material.

The device can be used extra-orally for similar purposes, that is, to roughen dental restorations to enhance bonding or to behave as a cleaning device.

## DESCRIPTION OF APPLICANT DEVICE
### ACCU-PREP™

ACCU-PREP is virtually identical to the MICROETCHER in design and function. The two models of the device, Type I and Type II are identical in design and function but differ cosmetically. That is Type I is nearly identical to the MICROETCHER and Type II is esthetically more pleasing. In addition, Type II has the abrasive reservoir in the center of the handpiece as opposed to the back end as in the MICROETCHER and it is completely autoclavable. The ACCU-PREP operates at somewhat lower minimum pressure than the MICROETCHER, 40 psig as opposed to 60.

## INTENDED USES OF APPLICANT DEVICE

ACCU-PREP is intended to be used to abrade and enhance the bond between the prepared tooth and cast dental metals for Maryland bridges, for cementation of cast metal restorations, for porcelain repair, as a porcelain etch substitute, to prepare indirect composite restorations for cementation, for repair of composite or resin restorations, repair of acrylic facings on cast restorations, endodontic post preparation, denture repairs, and orthodontic applications such as: preparation of brackets to enhance bonding, cement removal from brackets, and enhancement of adhesion to tooth structure.

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BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143
510(k) submission for ACCU-PREP™
31

# SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS

The scientific concepts of this device are basic. A relatively high velocity stream of compressed gas (air), when blown across the opening of a tube set at 90 degrees to the air stream creates a low pressure at the opposite end of the perpendicular tube. This low pressure (vacuum) sucks up an abrasive powder from a reservoir and propels the abrasive thereby abrading the surface of an object in its path. The phenomenon is analogous to a perfume bottle. The abrasive powder behaves as the perfume, that is, as air is blown across the opening the abrasive powder is blown into the air stream.

Comparison of ACCU-PREP to the predicate device shows both are very similar with the major difference being esthetics. The proposed new products, Types I and II, are functionally identical to the predicate device but are more esthetically acceptable top the patient as well as to the dentistry and dental auxiliary. One notable difference between the tow is the applicant device operates at lower air pressure.

Both employ 50 µm aluminum oxide as the primary abrasive but other grits can be used where appropriate. The range of normal grit sizes is 0.05 to 90 µm

Since both devices are appear essentially identical their performances were compared by testing in actual use situations. Shear bond tests were performed on human extracted teeth using identical conditions with the only difference being the device abrading the substrate. No statistically significant difference was found in this test at p ≥ 0.05. Examination of abraded surfaces using Scanning Electron Microscopy showed virtually identical results.

James L. Sandrik, Ph.D.
BISCO, Inc.
Itasca, IL 60143

February 7, 1997

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

Dr. James L. Sandrik, Ph.D.
Director of Technical Affairs
Bisco, Incorporated
1500 West Thorndale Avenue
Itasca, Illinois 60143

JUL 1 1997

Re: K970484
Trade Name: Accu-Prep
Regulatory Class: III
Product Code: KOJ
Dated: February 7, 1997
Received: February 10, 1997

Dear Dr. Sandrik:

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

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Page 2 - Dr. Sandrik

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 at [phone].

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

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BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143
510(k) submission for ACCU-PREP™
6

# INDICATIONS for USE

510(k) Number (if known): --

Device Name: **ACCU-PREP**

## Indications for Use:

1. **Maryland Bridges (resin bonded bridges)**: for preparation of cast metal framework of both non-precious (Ni-Cr) and noble (Au, Pt, Pd) alloys.
2. **Cast restoration cementation**: for preparation of intaglio surface of cast metal restorations to enhance micromechanical bonding especially of traditional cements (zinc phosphate).
3. **Porcelain repair**: for preparation of exposed metal (and porcelain) to repair failed porcelain fused to metal restoration intra-orally.
4. **Porcelain etch substitute**: for preparation of intaglio surface of porcelain restorations in place of etching with hydrofluoric acid in the mouth.
5. **Composite surface preparation substitute**: for preparation of intaglio surface of composite or polymeric restoration in place of surface active agents (i.e. methyl methacrylate).
6. **Composite/polymeric restoration repair**: for preparation of exposed failed restoration as in 5 above.
7. **Repair of acrylic facings on cast restorations**: for preparation of cast metal surface to enhance bond of self-cure acrylic facing to restoration.
8. **Endodontic post preparation**: for preparation of endo post to enhance micromechanical bond of post to prepared tooth.
9. **Denture repairs**: for preparation of denture base to facilitate repairs.
10. **Orthodontic applications**: for preparation of ortho brackets to enhance bonding to the bracket. For cement removal from brackets before re-bonding. For enhancement of adhesive to tooth structure.

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

Concurrence of CDRL, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐ (Optional Format 1-2-96)