(85 days)
Not Found
Not Found
No
The device description and performance studies focus on the laser technology and its clinical effectiveness, with no mention of AI or ML.
Yes
The device is used for the removal of caries and for cavity preparation, which are therapeutic interventions aimed at treating dental disease.
No
The device is described as being for "Removal of Caries and for Cavity Preparation," which are treatment procedures, not diagnostic ones.
No
The device description clearly outlines hardware components including a power supply, water cooling system, optical bench, fiber optic, and quartz contact tip, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For Removal of Caries and for Cavity Preparation in Primary and Secondary Teeth." This describes a direct treatment procedure performed on the patient's teeth.
- Device Description: The device is a dental laser system used for physical intervention (removing tissue).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health. This device does not perform such analysis.
The device is a therapeutic dental laser used for surgical procedures on teeth.
N/A
Intended Use / Indications for Use
For removal of caries and for cavity preparation in primary and secondary teeth.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
DeL2940 Dental Erbium Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. Delivery is via fiber optic with a quartz contact tip. At 10 pulses per second an a pulse energy of 1 Joules, the average power from the laser is 10 watts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Primary and secondary teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Data: Data was provided on two bovine studies (22 teeth) and two canine studies (174 teeth). One of the canine studies compared the laser treatment to the drill. All studies supported the safety and effectiveness of the Er: Y AG laser for caries removal and cavity preparation.
Clinical Performance Data: Foreign data was provided from four clinical studies for a total of 245 human teeth (18 extracted, 23 scheduled for extraction and 204 in vivo). All studies supported the safety and effectiveness of the Er.YAG laser for caries removal and cavity preparation. Domestic data was provided from an IDE study for a total of 94 pediatric subjects and 121 adult subjects treated with the DeL2940 Dental Erbium Laser.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K992013
510(k) Premarket Notification – Additional Information DeL2940 Dental Erbium Laser: Hard Tissue Disease Continuum Biomedical August 24, 1999
510(k) Summary
| Submitter: | Continuum Biomedical
A Medical Division of Continuum Electro-Optics, Inc.
6533 Sierra Lane
Dublin, CA 94568 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Laurie A. Ridener
Regulatory Affairs Officer |
| Date Summary
Prepared: | June 15, 1999 |
| Device Trade Name: | DeL2940 Dental Erbium Laser, DeLite Dental Erbium Laser |
| Common Name: | Medical laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Centauri Er: YAG Dental Laser System, Premier Laser Systems, Inc. |
| Device Description: | DeL2940 Dental Erbium Laser consists of three interconnected sections: the power supply,
the water cooling system and the optical bench. Delivery is via fiber optic with a quartz
contact tip. At 10 pulses per second an a pulse energy of 1 Joules, the average power from
the laser is 10 watts. |
| Intended Use: | For removal of caries and for cavity preparation in primary and secondary teeth. |
| Comparison: | The DeL2940 Dental Erbium Laser is substantially equivalent to the Centauri Er: Y AG Dental
Laser System (Premier). |
| Nonclinical
Performance Data: | Data was provided on two bovine studies (22 teeth) and two canine studies (174 teeth). One
of the canine studies compared the laser treatment to the drill. All studies supported the
safety and effectiveness of the Er: Y AG laser for caries removal and cavity preparation. |
| Clinical Performance
Data: | Foreign data was provided from four clinical studies for a total of 245 human teeth (18
extracted, 23 scheduled for extraction and 204 in vivo). All studies supported the safety and
effectiveness of the Er.YAG laser for caries removal and cavity preparation. Domestic data
was provided from an IDE study for a total of 94 pediatric subjects and 121 adult subjects
treated with the DeL2940 Dental Erbium Laser. |
| Conclusion: | The DeL2940 Dental Erbium Laser is substantially equivalent to other currently marketed
erbium dental lasers for the removal of caries and for cavity preparation in primary and
secondary teeth. |
| Additional Information: | None requested at this time. |
PROPRIETARY DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continum Biomedical, A Medical Division of Continum Electro-Optics, Inc.,
1
Image /page/1/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 symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 1999
Ms. Liza A. Burns Regulatory Affairs Consultant Continuum Biomedical, Inc. 6533 Sierra Lane Dublin, California 94568
Re: K992013
Trade Name: DeL2940 Dental Erbium Laser, DeLite Dental Erbium Laser Regulatory Class: II Product Code: GEX Dated: June 15, 1999 Received: June 15, 1999
Dear Ms. Burns:
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.
2
Page 2 - Ms. Liza A. Burns
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 vour 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,
Sincerely, years,
Sallie M. Weaver, 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
3
| 510(k) Number (if known): | K992013 |
|---|---|
| Device Name: | DeL2940 Dental Erbium Laser, DeLite Dental Erbium Laser |
| Indications for Use: | For Removal of Caries and for Cavity Preparation in Primary and Secondary Teeth. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992013 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR Over-the-Counter Use |
(Optional Format 1-2-96)
PROPRIETAR Y DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continual Biomedical. A Medical Division of Continuan Electro-Optics, Inc.