(84 days)
Opus 10TM Dental Diode Laser System (OpusDent Ltd.), TwiliteTM Dental Diode Laser system (Biolase Technology, Inc.), AuroraTM Diode Laser System (Premier Laser Systems, Inc.), DentekTM LD 15 Diode laser (DentekTM Austria GMBH)
Not Found
No
The summary describes a standard dental diode laser system with adjustable power and pulse, and does not mention any AI or ML capabilities.
Yes
The device is intended for various medical procedures, including incision, excision, ablation, vaporization, and coagulation of oral soft tissue, as well as therapeutic uses in endodontology and periodontology, which are all methods of treating a disease or disorder.
No
The device is described as a laser system for incision, excision, ablation, vaporization, and coagulation of oral soft tissue, as well as teeth whitening. These are all therapeutic and cosmetic procedures, not diagnostic ones.
No
The device description explicitly states it is a "Dental Diode Laser System" and describes hardware components like a "Gallium Aluminum Arsenide (GaAIAs) solid state laser diode" and a "fiber optic held by an handpiece." This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Opus 10™ Function: The Opus 10™ Dental Diode Laser System is a therapeutic device that uses laser energy to perform procedures directly on oral soft tissue and teeth. It is used for incision, excision, ablation, vaporization, coagulation, and teeth whitening.
- Lack of Specimen Examination: The device does not examine specimens derived from the human body in a laboratory setting. It interacts directly with the patient's tissues and teeth.
The intended use and device description clearly indicate that this is a surgical and aesthetic device used for direct treatment, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Opus 10TM Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.
The Indications for Use of the Opus 10TM Dental Diode Laser System include:
Cosmetic Dentistry
- Light activation for bleaching materials for teeth whitening
- Laser-assisted bleaching/whitening of the teeth
Endodontology
- Pulpotomy
- Pulpotomy as an adjunct to root canal therapy
Periodontology
- Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket)
Oral Soft Tissue Surgery
- Biopsy
- Operculectomy
- Gingivectomy
- Gingivoplasty
- Papillectomy
- Lesion (tumor) removal
- Leukoplakia
- Treatment of aphthous ulcers
- Fibroma removal
- Frenectomies and frenotomies
- Tissue retraction for impressions
- Incising and draining of abscesses
- Exposure of unerupted teeth
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Opus 10TM Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures.
A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues.
A fiber optic held by an handpiece delivers the Opus 10TM laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva)
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)
Not Found
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.
Opus 10TM Dental Diode Laser System (OpusDent Ltd.), TwiliteTM Dental Diode Laser system (Biolase Technology, Inc.), AuroraTM Diode Laser System (Premier Laser Systems, Inc.), DentekTM LD 15 Diode laser (DentekTM Austria GMBH)
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
AUG 3 0 2001
510(K) SUMMARY
OPUS 10TM DENTAL DIODE LASER SYSTEM
510(k) Number K ଠୀ / 7 ሬ ¶
Applicant's Name:
OpusDent Ltd. Atid Science Based industrial Park, Hagavish 4 St., Natania south P.O.Box 8737 Natania 42505, Israel Tel.: 972-9-892 3333 Fax: 972-9-892 3300
or:
Contact Person:
Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131
Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth St, NW Washington, DC 20004 Tel: (202) 637-5794 Fax: (202) 637-5910
Date Prepared:
June 2001
Trade Name:
Opus 10TM Dental Diode Laser System
Classification Name:
Laser Instrument, Surgical, Powered
Classification:
FDA has classified laser device as a class II device (product code GEX) and it is reviewed by the General & Plastic Surgery Panel.
1
1176974
Predicate Devices:
The Opus 10™ Dental Diode Laser System with the tooth whitening application is substantially equivalent to the Opus 10TM Dental Diode Laser System (OpusDent Ltd.) in terms of, technological characteristics, performance, intended use (generally), indications for use and user interface.
In addition, the Opus 10TM is substantially equivalent to a combination of the Twilite™ Dental Diode Laser system (Biolase Technology, Inc.), to the Aurora™ Diode Laser System (Premier Laser Systems, Inc.) and to the Dentek™ LD 15 Diode laser (Dentek™ Austria GMBH) in terms of intended use, indication for use, technological characteristics and performance.
Performance Standards:
The Opus 10TM Diode Laser complies with:
U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products.
In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the voluntary standards, EN 60601-1, EN-60825-1, EN-601-2-22, CISPR 11, IEC 61000-4-2/3/4/5, EN55011 and IEC 801-2
2
011769 3/4
Intended Use / Indication for Use:
The Opus 10TM Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.
The Indications for Use of the Opus 10™ Dental Diode Laser System include:
Cosmetic Dentistry
- Light activation for bleaching materials for teeth whitening ●
- Laser-assisted bleaching/whitening of the teeth .
Endodontology
- Pulpotomy .
- Pulpotomy as an adjunct to root canal therapy .
Periodontology
-
Sulcular debridement (removal of diseased or inflamed soft tissue in the . periodental pocket)
Oral Soft Tissue Surgery -
Biopsy ◆
-
. Operculectomy
-
Gingivectomy ●
-
◆ Gingivoplasty
-
. Papillectomy
-
Lesion (tumor) removal .
-
Leukoplakia .
-
Treatment of aphthous ulcers .
-
Fibroma removal .
-
. Frenectomies and frenotomies
-
Tissue retraction for impressions
-
Incising and draining of abscesses
-
. Exposure of unerupted teeth
Device Description:
The Opus 10TM Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures.
A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues.
3
G11 769 4/4
A fiber optic held by an handpiece delivers the Opus 10™ laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.
Substantial Equivalence:
There are no unique applications, indications, material or specifications presented herein. Evidence of equivalence has been demonstrated through:
- The Opus 10TM intended use and indications for use were previously . cleared by FDA for the predicate devices.
- The technical characteristics of the Opus 10™ with the tooth whitening . application are similar to those of the cleared Opus 10TM, Twilite™, Aurora™ and Dentek™
- Laser output values of the Opus 10™ are well within previous cleared ◆ values of the predicate dental diode laser systems as described.
- The predicate devices and other previous cleared lasers with similar energy . output has a proven safety and effectiveness in the treatment of the claimed indications.
- . Safety and performance testing.
Therefore, the Opus 10TM Dental Diode Laser System with the tooth whitening application is substantially equivalent to its predicate devices cited above and raises no new safety and/or effectiveness issues.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with flowing lines beneath them that resemble fabric or water.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
OpusDent Ltd. c/o Ms. Shoshana Friedman, RAC Push-Med, Ltd. 117 Ahuzah Street Ra'ananna 43373 Israel
Re: K011769
Trade/Device Name: Opus 10TM Dental Diode Laser System Regulation Number: 878.4810 Regulatory Class: II Product Code: GEX Dated: June 2, 2001 Received: June 7, 2001
Dear Ms. Friedman:
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 legally marketed predicate 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 requirements, 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.
5
Page 2 - Ms. Shoshana Friedman, RAC
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 notification. The I Dri imaling of succianter 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 CFF Part 801 and If you desire specific acrice for your ostic devices), please contact the Office of Compliance at additionally 607.10 for m Priro Chagliestions on the promotion and advertising of your device, (201) 594-4639. Radinonaly, and (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1011) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours
Susan Wesson, M.D.
for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known): K011769
Device Name: Opus 10™ Dental Diode Laser System
Indications for Use: The Opus 10™ Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.
The Indications for Use of the Opus 10™ Dental Diode Laser System include:
Cosmetic Dentistry
- · Light activation for bleaching materials for teeth whitening
- · Laser-assisted bleaching/whitening of the teeth
Endodontology
- · Pulpotomy
- · Pulpotomy as an adjunct to root canal therapy
Periodontology
- · Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket)
Oral Soft Tissue Surgery
- · Biopsy
- · Operculectomy
- Gingivectomy .
- · Gingivoplasty
- Papillectomy .
- · Lesion (tumor) removal
- · Leukoplakia
- · Treatment of aphthous ulcers
- · Fibroma removal
- Frenectomies and frenotomies
- Tissue retraction for impressions
- Incising and draining of abscesses
- Exposure of unerupted teeth
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number K011764
Prescription Use
(Per 21 CFR 801. 109)
OR
SvL
(Division Sign Off) Use
At the Counter Use
Division of General, Restorative and Neurological Devices
10-8
510(k) Number -