JETSTREAM CAVITY PREPARATION SYSTEM

K955050 · Dove Systems, Inc. · KOJ · Mar 7, 1996 · Dental

Device Facts

• Record ID: K955050
• Device Name: JETSTREAM CAVITY PREPARATION SYSTEM
• Applicant: Dove Systems, Inc.
• Product Code: KOJ · Dental
• Decision Date: Mar 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jetstream System is a pneumatic device which combines pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The Jetstream is capable of removing dental caries, old composite restoration materials, as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials.

Device Story

Jetstream Cavity Preparation System is a pneumatic dental device; uses pressurized air to propel 50μ aluminum oxide particles through a handpiece. Operates in pulse or continuous modes (40-120 psi). Used by dentists in clinical settings for cavity preparation, removal of caries/old composite, and surface modification for bonding. System includes console, handpiece, and footswitch. Output is a high-velocity abrasive stream; allows precise removal of tooth structure or restorative materials. Benefits include effective surface preparation for dental restorations.

Clinical Evidence

No clinical data provided. Safety assessment based on literature review of adverse events associated with kinetic cavity preparation systems, including soft tissue injury, subcutaneous air/particle injection, and infection.

Technological Characteristics

Pneumatic abrasive system; uses 50μ aluminum oxide powder. Delivery via handpiece powered by compressed air (40-120 psi). Console-based with touch pad membrane switches. Operates on 100-240V, 50/60 Hz. Pulse and continuous operating modes.

Indications for Use

Indicated for cavity preparation, removal of decayed and sound tooth structure, removal of restoration materials, preparation for pit and fissure sealant, and modification of enamel and dentin for increased bond strength.

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

• KCP 2000 Cavity Preparation System (K921748)
• Microprep Cavity Preparation System (K932997)
• Kv-1 Cavity Preparation System (K940776)

Submission Summary (Full Text)

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K953050
K953050
MAR - 7 1996

# Appendix V
## Summary of Safety and Effectiveness Information

133

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134

# Section 510(k)
## Premarket Notification

### Summary of Safety and Effectiveness Information

**Regulatory Authority:** Safe Medical Devices Act of 1990, 21 CFR 807.92

**Company Name:**

Dove Systems, Inc.
4280 Higuera Road
San Jose, CA 94328
[phone]

**Company Contact Regulatory Affairs:**

Arthur Vassiliadis, Ph.D.
Dove Systems, Inc.
4280 Higuera Road
San Jose, CA 94328
[phone]

**Device Name:**

Jetstream Cavity Preparation System.

**Predicate Devices:**

KCP 2000 Cavity Preparation System (American Dental Laser, Troy, Michigan) Microprep Cavity Preparation System (Sunrise Technologies, Inc.) Kv-1 Cavity Preparation System (Kreativ, Inc.)

**Device Description:**

The Jetstream System is a pneumatic device which combines pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations.

The Jetstream is capable of removing dental caries, old composite restoration materials, as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small handpiece which is approximately the size of a high-speed dental drill.

The Jetstream consists of a console, handpiece, and a footswitch. Specifications for the Jetstream System are provided in the table below. The console houses the system pneumatics, simple, easy to use controls, and canisters for holding the particulate supply. The system is designed for easy service and maintenance with easily accessed and refillable canisters for the particulate supply.

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Comparison With Predicate Device:

| FEATURE | Jetstream | Microprep | Kv-1 | KCP 2000 | SE? |
| --- | --- | --- | --- | --- | --- |
| Cutting material | Aluminum Oxide Powder 50μ particles | Aluminum Oxide Powder 50μ particles | Aluminum Oxide Powder 27μ & 50μ particles | Aluminum Oxide Powder 27μ & 50μ particles | Yes |
| Velocity settings | Continuously Variable 40-120 psi | Continuously Variable 80-120 psi | Continuously Variable 40-120 psi | Slow, Medium, High (40-120-140) psi | Yes |
| Delivery medium | Compressed Air - Wall source | Compressed Air - Internal Compressor | Compressed Air - Wall source | Compressed Air - Wall source | Yes |
| Operating modes | Pulse & Continuous | Pulse & Continuous | Pulse & Continuous | Continuous Only | Yes |
| Evacuation | Other Evacuator | Proprietary - "Quickevac" | Other Evacuator | Built In | Yes |
| Electrical | 100-240V, 50/60 Hz | 110-220-240V 50/60 Hz | 100-240V, 50/60 Hz | 110V | Yes |
| Controls | Touch Pad Membrane Switches | Touch Pad Membrane Switches | Touch Pad Membrane Switches | Touch Pad Membrane Switches | Yes |
| Delivery system | Handpieces | Handpieces | Handpieces | Handpieces | Yes |
| Indications | Cavity Preparation
Removal of decayed and sound tooth structure
Removal of restoration materials
Prep for pit and fissure sealant
Modification of enamel and dentin for increased bond strength | Cavity Preparation
Removal of decayed and sound tooth structure
Removal of restoration materials
Prep for pit and fissure sealant
Modification of enamel and dentin for increased bond strength | Cavity Preparation
Removal of decayed and sound tooth structure
Removal of restoration materials
Prep for pit and fissure sealant
Modification of enamel and dentin for increased bond strength | Cavity Preparation
Removal of decayed and sound tooth structure
Removal of restoration materials
Prep for pit and fissure sealant
Modification of enamel and dentin for increased bond strength | Yes |
| K-Number | Pending | K932997 | K940776 | K921748 | Yes |

Summary of Adverse Product Experience:

As of September 1995, Dove Systems, Inc. conducted a database search of the published literature to identify adverse use experience with cavity preparation systems. This literature review revealed the following adverse event experience with cavity preparation systems.

1. Cutting of adjacent soft tissue.
2. Subcutaneous injection of air and/or air and abrasive particles.
3. Etching of adjacent tooth surface.
4. Reduced effect on existing gold or amalgam restorations
5. Infection

Additional Information

A bibliography of selected articles is available from Dove Systems, Inc. upon request.

Conclusions:

Based on the comparison of the technical specifications of the Jetstream Cavity Preparation System with the KCP 2000 Kinetic Cavity Preparation System, the Microprep Cavity Preparation System, and with the Kv-1 Cavity Preparation System, the company concludes that the Jetstream Cavity Preparation System is substantially equivalent. Dove Systems, Inc. believes that the the Jetstream Cavity Preparation System may reasonably be expected to be safe and effective when used according to its labeling by properly trained individuals. The adverse events identified with the use of the Jetstream are the same or similar to the adverse events associated with the use of the referenced equivalent devices.