(56 days)
Not Found
No
The device description focuses on the physical components, light output, and curing capabilities of a dental polymerization lamp. There is no mention of any computational processing, algorithms, or learning capabilities that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes.
The device cures restorative composite materials for dental fillings, which is a therapeutic intervention to treat dental cavities.
No
The device is a polymerization lamp used to cure dental materials, which is a therapeutic function, not a diagnostic one. It facilitates the hardening of
restorative composites, which is a treatment step.
No
The device is a physical lamp with a halogen bulb, light filter, handpiece, and cable, clearly indicating it is a hardware 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 the "Polymerization of light-cured dental materials" and "Polymerization of restorative composite materials." This is a therapeutic/restorative function performed directly on the patient's teeth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a light-curing lamp used to harden dental materials. This is a physical process applied to materials within the patient's mouth.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for use in a dental setting to facilitate the physical curing of dental materials during restorative procedures. This falls under the category of a dental device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
- Polymerization of light-cured dental materials
- Polymerization of restorative composite materials
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
LCxx00 Compacta lamp is a polymerization lamp which provides light primarily in the range between 400 - 515 nm and is capable of curing light-cured dental materials. It is a component intended for integration in a standard dental unit and the light source is supplied with power from the unit. Compressed air for cooling of the handpiece is also provided from the unit.
The LCxx00 Compacta lamp is supplied with a 25 Watt, 40W, 60W or 80W halogen bulb. The visible light from the bulb is filtered to provide a wavelength between 400 and 515 nm which is directed to a light guide with an 8mm diameter. Light in this wavelength range is able to cure light composit material used for dental fillings.
The output from the LCxx00 Compacta through the autoclayable, detachable light guide is approximately 530 mW/cm² , 750 mW/cm² , 1080 mW/cm², 1440 mW/cm2 respectively, in total. Within the range of 400 - 515 nm the lamp has an output of approx. 390 mWlcm², 590 mW/cm2 , 825 mW/cm2 , 1180 mW/cm2 respectively. These measurements are carried out according to requirements in ISO/DIS 10650.2.
This light cures the restorative composite materials to a depth of about 5.5 mm, 5.7 mm, 6.0 mm, 6.7 mm respectively in 40 seconds. The composite is cured 100 % to a depth of 2.4 mm, 2.5 mm, 2.7mm and 3.1 mm respectively.
The halogen bulb is built into a handpiece which is ergonomically shaped so that it is comfortable and easy to use for a dentist. The housing of the handpiece is made of thermoplastic material. Excessive heat is cooled by air from the dental unit and if the cooling air should fail, a built in thermal fuse and a thermal switch will disconnect the electrical connection.
The LCxx00 Compacta is supplied with power and with air from the dental unit via a cable. This cable has a connector so that it is detachable from the handpiece.
The handpiece contains a bayonet-like connector which enables the front section to be detached from the rear section so that the halogen bulb and the light filter can be exchanged by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
will be used as a component to be integrated into a dental unit and will be marketed as an integral part of the dental unit.
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)
The output from the LCxx00 Compacta through the autoclayable, detachable light guide is approximately 530 mW/cm² , 750 mW/cm² , 1080 mW/cm², 1440 mW/cm2 respectively, in total. Within the range of 400 - 515 nm the lamp has an output of approx. 390 mWlcm², 590 mW/cm2 , 825 mW/cm2 , 1180 mW/cm2 respectively. These measurements are carried out according to requirements in ISO/DIS 10650.2.
This light cures the restorative composite materials to a depth of about 5.5 mm, 5.7 mm, 6.0 mm, 6.7 mm respectively in 40 seconds. The composite is cured 100 % to a depth of 2.4 mm, 2.5 mm, 2.7mm and 3.1 mm respectively.
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.
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
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the word "LYSTAV" in a bold, sans-serif font. The letters are black and have a horizontal striped pattern. The background is white.
AUG 27 1999
510(k) SUMMARY
Submitter Information A.
Lysta AJS Gammelgaardsvej 102 DK-3520 Farum Denmark
Telephone: Fax:
+45 4495 3000 +45 4495 3010
Contact Person:
Erling Mortensen Quality Coordinator
Date Prepared:
June 28, 1999
B. Device Identification
Common/Usual Name: Proprietary Name:
Polymerization Light-Curing Device LCxx00 Compacta consisting of: LC2500 Compacta LC4000 Compacta LC6000 Compacta LC8000 Compacta
C. Identification of Predicate Device
The LCxx00 Compacta is substantialy equivalent to its predicate device the Lysta LC2500 C/BA (K991138) previously cleared and currently marketed.
D. Device Description and performance data
LCxx00 Compacta lamp is a polymerization lamp which provides light primarily in the range between 400 - 515 nm and is capable of curing light-cured dental materials. It is a component intended for integration in a standard dental unit and the light source is supplied with power from the unit. Compressed air for cooling of the handpiece is also provided from the unit.
The LCxx00 Compacta lamp is supplied with a 25 Watt, 40W, 60W or 80W halogen bulb. The visible light from the bulb is filtered to provide a wavelength between 400 and 515 nm which is directed to a light guide with an 8mm diameter. Light in this wavelength range is able to cure light composit material used for dental fillings.
1
The output from the LCxx00 Compacta through the autoclayable, detachable light guide is approximately 530 mW/cm² , 750 mW/cm² , 1080 mW/cm², 1440 mW/cm2 respectively, in total. Within the range of 400 - 515 nm the lamp has an output of approx. 390 mWlcm², 590 mW/cm2 , 825 mW/cm2 , 1180 mW/cm2 respectively. These measurements are carried out according to requirements in ISO/DIS 10650.2.
This light cures the restorative composite materials to a depth of about 5.5 mm, 5.7 mm, 6.0 mm, 6.7 mm respectively in 40 seconds. The composite is cured 100 % to a depth of 2.4 mm, 2.5 mm, 2.7mm and 3.1 mm respectively.
The halogen bulb is built into a handpiece which is ergonomically shaped so that it is comfortable and easy to use for a dentist. The housing of the handpiece is made of thermoplastic material. Excessive heat is cooled by air from the dental unit and if the cooling air should fail, a built in thermal fuse and a thermal switch will disconnect the electrical connection.
The LCxx00 Compacta is supplied with power and with air from the dental unit via a cable. This cable has a connector so that it is detachable from the handpiece.
The handpiece contains a bayonet-like connector which enables the front section to be detached from the rear section so that the halogen bulb and the light filter can be exchanged by the user.
ய் Substantial Equivalence
The LCxx00 Compacta is, in relative technical terms, almost identical to the predicate device. Relative technical and physical differences are insignificant and are not relevant with regard to safety and effectiveness during use. The smallest of the four Compacta lamp versions (LC2500 Compacta) is identical to the predicate device as far as capacity is concerned.
F. The Product's Use
The LCxx00 Compacta will be used as a component to be integrated into a dental unit and will be marketed as an integral part of the dental unit.
The function of the lamp on the unit is to polymerize dental composite materials for restoration of cavity preparation, curing of bonding and other photo-curing restorative materials as well as any application where a conventional dental curing light would be used.
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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 features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Mr. Gregers Lystager Managing Director Lysta A/S Gammelgaardsvej 102 DK-3520 Farum Denmark
K992236 Re : Lysta LC Compacta Curing Light, Models Trade Name: LC2500 Compacta, LC4000 Compacta, LC6000 Compacta LC8000 Compacta Regulatory Class: II Product Code: EBZ June 28, 1999 Dated: Received: July 2, 1999
Dear Mr. Lystager
ーで
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ત substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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
3
Page 2 - Mr. Lystager
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.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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.fdal.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Directbr Divisibn of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
Page 1 of 1
510 (k) Number (if known):
Device Name: Lysta LCxx00 Compacta consisting of: LC2500 Compacta LC4000 Compacta LC6000 Compacta LC8000 Compacta
Indications for use:
- · Polymerization of light-cured dental materials
- · Polymerization of restorative composite materials
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over The Counter Use __
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 12992231