(84 days)
Laser-assisted Bleaching/Whitening of the teeth. Illumination purposes for the adjunctive use in caries detection and endodontic orifice location. Curing of all light sensitive bonding materials including: Pit and fissure sealants, composite restorations, endodontic composite cores, composite cements for porcelain facings and inlays, periodontal splint material, and prosthetic reline and repair material.
The Dental 200, 300, & 400 Laser Systems are an instrument used in the application of Dentistry. With a level of output power of up to 10.0 Watts on some models, and the selectable blue or green wavelengths, additional indications for use are warranted. The use of these dental laser devices are supported by a line of FiberFlex™ Fibers in sizes of; 200, 300, 400, & 600 microns. Cannulas specifically designed for use in Dentistry and as companion to the bare fibers. The primary energy output source is an Argon Ion laser head for delivery to the patient. The selectable laser wavelength colors of green (treat) and blue (cure). This system has similar timing features for interval, and duration. The Aiming Beam is a visible Red Diode @ 630-680nm.
This document is a 510(k) premarket notification for the Dental 200, Dental 300, and Dental 400 Argon Laser Systems. It establishes substantial equivalence by comparing the submitted devices to predicate devices. As such, it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not on proving new performance claims against defined criteria through a study.
Therefore, I cannot provide the requested information from this document. Here's why:
- Acceptance criteria and reported device performance: This document describes the functional characteristics of the device and compares them to predicate devices, but it does not specify quantitative acceptance criteria (e.g., "device must achieve X % accuracy") or report performance data against such criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set: These are all elements typically found in a clinical study report or performance validation report, which are not part of this 510(k) summary. The summary focuses on design and functional similarity to predicates.
In a 510(k) submission, the "study" that proves the device meets acceptance criteria is often a bench testing comparison to a predicate device or analysis of existing literature about the predicate device's performance, rather than a de novo clinical trial with specific performance endpoints. The "acceptance criteria" are implied by the performance of the predicate device.
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JUL 20 1999
FISMA INC., 3959 West 1820 South Salt Lake City, Utah 84104 (801) 972-0500 (801) 972-4884 (fax) Tracy S. Best, Regulatory Manager Preparation Date: April 26, 1999
Summary of Safety and Effectiveness for the:
Dental 200, Dental 300, Dental 400 Trade Name: Argon Laser System Common Name: Laser, Instrument, Surgical, Powered - 79 GEX Classification Name:
Legally Marketed Predicate Devices for Substantial Equivalence:
-
Arago II, Argon Laser by: Premier Laser Systems
-
Elite Family of Lasers, KTP Green by: FISMA Inc.
Rationale for SE: The Dental 200, 300, & 400 Lasers and Delivery Devices share similar indications for use, and similar design features including; wavelengths, beam integrity, and cooling type. Control systems such as interlock devices. (safety systems) and displays are constantly monitored for user intervention. Functional features such as; delivery power, pulse rates, energy type, and spot sizes are also similar. See Attachment "A" Comparison Chart of Equivalence.
Description of Submitted Device:
The Dental 200, 300, & 400 Laser Systems are an instrument used in the application of Dentistry. With a level of output power of up to 10.0 Watts on some models, and the selectable blue or green wavelengths, additional indications for use are warranted. The use of these dental laser devices are supported by a line of FiberFlex™ Fibers in sizes of; 200, 300, 400, & 600 microns. Cannulas specifically designed for use in Dentistry and as companion to the bare fibers.
Intended Use the Dental Lasers:
Laser-assisted Bleaching/Whitening of the teeth, Curing of all light sensitive bonding materials, (i.e., pit and fissure sealants, composite restorations, endodontic composite cores, composite cements for porcelain facings and inlays, periodontal splint material, and prosthetic reline and repair material). Also, Illumination purposes for the adjunctive use in caries detection and endodontic orifice location.
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Technological Characteristics and Substantial Equivalence:
The Dental 200, 300, & 400 primary energy output source is an Argon Ion laser head for delivery to the patient. The selectable laser wavelength colors of green (treat) and blue (cure). Refer to the of Substantial Equivalence showing the individual system settings for these three lasers. This system has similar timing features for interval, and duration. The Aiming Beam is a visible Red Diode @ 630-680nm.
The Arago II Laser (Premier Laser Systems) uses identical wavelengths as the primary source of energy for delivery to the patient. The Arago II Laser System delivers similar power, spot sizes and pulses of equivalent duration. Indications for use are equivalent. The Aiming Beam is also a visible Red Diode.
The Elite Family Lasers are a diode-pumped system which delivers 532 nm laser light. These use a diode as the primary source of energy which is then converted to visible green 532 nm for delivery to the patient and treatment. The system delivers similar average power, durations and intervals. Although the wavelength is different, the final treatment results to the patient is identical. The Aiming Beam is a visible Red Diode @630-680nm.
Conclusion:
The Dental Laser Systems are substantially equivalent to other existing surgical laser systems in commercial distribution. Therefore a finding of substantial equivalence is requested for this submission.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 1999
Mr. Tracy S. Best Regulatory Manager FISMA, Inc. 3959 West 1820 South Salt Lake City, Utah 84104
K991464 Re:
Trade Name: Dental 200, Dental 300, Dental 400 Regulatory Class: GEX Product Code: II Dated: April 26, 1999 Received: April 27, 1999
Dear Mr. Best:
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 - Mr. Tracy S. Best
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K991464 |
|---|---|
| --------------------------- | --------- |
Device Name: Dental 200, Dental 300, Dental 400
Indications For Use:
โ Laser-assisted Bleaching/Whitening of the teeth.
- V Illumination purposes for the adjunctive use in caries detection and endodontic orifice location.
- V Curing of all light sensitive bonding materials including: Pit and fissure sealants, composite restorations, endodontic composite cores, composite cements for porcelain facings and inlays, periodontal splint material, and prosthetic reline and repair material.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off)
meral Restorative Devices K991464
on, Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use .
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.