(88 days)
ADT 1000 Plasma Arc Curing System
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No
The summary describes a light-based curing device with no mention of AI or ML capabilities, image processing, or data analysis.
No
The device is used for curing dental materials, not for treating or diagnosing a disease or condition in a patient.
No
The device is described as a curing lamp for composite resin materials, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "high intensity light source that is filtered and transmitted through a liquid optical fiber," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the Sunrise Curing Lamp is to cure composite resin materials in the mouth, directly on the tooth. It does not involve analyzing blood, urine, tissue, or any other bodily fluid or sample.
- The device description focuses on a light source for curing materials. It doesn't mention any analytical or diagnostic function.
- The intended use is for a therapeutic/restorative procedure. Curing composite resins is a step in restoring a tooth, not diagnosing a condition.
Therefore, the Sunrise Curing Lamp falls under the category of a dental device used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tooth
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ADT 1000 Plasma Arc Curing System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.
0
K962192 ✓
SEP 3 1000
SUNRISE
TECHNOLOGIES
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
(510) 623-9001 |
| 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)
Sunrise Curing Lamp 510(k)
00043
Sunrise Technologies, Inc. • 47257 Fremont Boulevard, Fremont, CA 94538 • (510) 623-9001 FAX (510) 623-9008
1
EQUIVALENCE IV:
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, 1 A |
| 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 | 420mm 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)