SUNRISE CURING LAMP

K962192 · Sunrise Technologies, Inc. · EBF · Sep 3, 1996 · Dental

Device Facts

• Record ID: K962192
• Device Name: SUNRISE CURING LAMP
• Applicant: Sunrise Technologies, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sunrise Curing Lamp is indicated for use in curing of composite resin materials for restoration of cavity preparation, curing of bonding materials, and any application where a conventional halogen curing lamp would be used.

Device Story

High-intensity light source for dental composite resin curing; utilizes xenon short arc lamp; light filtered and transmitted via liquid optical fiber to tooth. Operated by dental professionals in clinical settings. Device features adjustable curing duration (1-99 seconds) and power output (400mW ± 50mW). User controls include front panel power switch, duration touchpads, and handpiece light switch. System performs calibration prompts at power-on sequence. Output enables polymerization of dental restorative materials, facilitating cavity preparation procedures.

Clinical Evidence

No clinical data. Substantial equivalence based on technical performance specifications and comparison to predicate device.

Technological Characteristics

Xenon short arc lamp light source; liquid light guide (1.8m length); fiber-optic tip (6mm diameter); optical bandwidth 420nm-500nm; power output 400mW ± 50mW; 115V/230V power input; digital LED display for curing time; front panel calibration port.

Indications for Use

Indicated for dental professionals requiring a high-intensity light source for curing composite resins and bonding materials during cavity restoration or other procedures where conventional halogen curing lamps are utilized.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• ADT 1000 Plasma Arc Curing System

Submission Summary (Full Text)

{0}

K962192

SUNRISE

TECHNOLOGIES

SEP 3 1996

510(k) Summary

# SUMMARY OF SAFETY AND EFFECTIVENESS

Regulatory Authority: Safe Medical Devices Act of 1990, Section 513. 21 CFR 807.92

Company Name: Sunrise Technologies, Inc.
47257 Fremont Blvd.
Fremont, CA 94538
[phone]

Device Name: Sunrise Curing Lamp

Predicate Device: ADT 1000 Plasma Arc Curing System

Device Description: The Sunrise Curing Lamp is a high intensity light source that is filtered and transmitted through a liquid optical fiber to the tooth for curing of composite resins.

Intended Use: The Sunrise Curing Lamp is indicated for use in curing of composite resin materials for restoration of cavity preparation, curing of bonding materials, and any application where a conventional halogen curing lamp would be used.

Comparison With Predicate Device: See accompanying table.

Additional Information: A bibliography of selected articles is available from Sunrise Technologies, Inc. upon request.

Conclusion: Based on the favorable comparison of the technical performance specifications of the Sunrise Curing Lamp with the ADT 1000 Plasma Arc Curing Lamp, the company concludes that these substantially equivalent devices are safe and effective when used by properly trained individuals.

Sunrise Technologies, Inc. Date

Sunrise Curing Lamp 510(k)

00043

Sunrise Technologies, Inc. • 47257 Fremont Boulevard, Fremont, CA 94538 • [phone]

FAX [phone]

{1}

# IV: EQUIVALENCE

## A. General

The Sunrise Curing Lamp is substantially equivalent to the ADT 1000 Plasma Arc Curing System marketed by American Dental Technologies, Inc., San Carlos, California. The table below compares the features of these two equivalent systems. Please see Section 15 for a copy of predicate device ADT 1000 Plasma Arc Curing System Operator Manual.

| Features | ADT 1000 Plasma Arc Curing System | Sunrise Curing Lamp |
| --- | --- | --- |
| Power Input | Provided by KCP 1000 | 115V~, 50/60 Hz, 2A
230 V~, 50/60 Hz, 1A |
| Light Source | Xenon short arc lamp | Xenon short arc lamp |
| Curing Power Output | 270mW to 850mW | 400mW ± 50mW |
| Duration | 10 sec. to 25 sec. | Default 10 sec.
Adjustable 1 to 99 sec. |
| Optical Bandwidth | 430nm to 500nm | 420nm to 500nm |
| Beam Delivery | Liquid Light Guide, 1.7m Length.
Rotating Handpiece.
Fiber-optic Tip, 6.5 mm dia. | Liquid Light Guide, 1.8m Length
Rotating Handpiece
Fiber-optic Tip, 6mm dia. |
| User Controls | Footswitch (for KCP 1000) | Power ON/OFF - Switch on front panel
Duration set - Increment/ decrement touchpads on front panel
Light ON/OFF - Switch on handpiece |
| Calibration | Port on front panel. | Prompted at each power ON sequence
Port on front panel |
| Indicators | Two 7 segment LED digital indicators, curing time in seconds. | Power ON Calibration
2 digit display (curing time in seconds). |

Sunrise Curing Lamp 510(k)

00041

5