(75 days)
Not Found
No
The summary describes a standard dental curing light and makes no mention of AI or ML.
No
A therapeutic device is one that treats a disease or condition. This device is used for curing dental resin products, which is a restorative function, not a therapeutic one in the medical sense.
No
The device description states its purpose is for "curing of dental VLC resin products" and to "photoactivate dental resin products," which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "visible light emitting photopolymerization unit," indicating it is a hardware device that emits light, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visible light irradiation for curing dental resin products. This is a physical process applied to a material, not a diagnostic test performed on a biological sample.
- Device Description: The description confirms it's a light-emitting unit for photoactivating dental resin. Again, this relates to material processing, not biological analysis.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a dental curing light, which is a common type of medical device used in dentistry for hardening resin-based materials.
N/A
Intended Use / Indications for Use
The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
The SPECTRUM™ 800 CURING UNIT is a visible light emitting photopolymerization unit that produces light used to photoactivate dental resin products.
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
Prescription Use
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.
Spectrum™ Curing Light K951425
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
§ 872.3690 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
SEP 1 5 1998
DENTSPLY
510(k) SUMMARY
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 777 8542343
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
June 29, 1998 DATE PREPARED:
TRADE OR PROPRIETARY NAME: SPECTRUM™ 800 CURING UNIT
CLASSIFICATION NAME: Unclassified
Visible light activator for polymerization COMMON OR USUAL NAME:
Spectrum™ Curing Light K951425 PREDICATE DEVICES:
DEVICE DESCRIPTION: The SPECTRUM™ 800 CURING UNIT is a visible light emitting photopolymerization unit that produces light used to photoactivate dental resin products.
INTENDED USE: The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.
TECHNOLOGICAL CHARACTERISTICS: The SPECTRUM™ 800 CURING UNIT is identical to the Spectrum™ Curing Light (K951425) except for cosmetic changes to the appearance and operating features and an increased wattage light bulb. The same filter used for the Spectrum™ Curing Light is used for the SPECTRUM™ 800 CURING UNIT and controls the wavelength of light that is emitted by the unit. Both curing units feature a radiometer built into the base. However, the SPECTRUM™ 800 CURING UNIT radiometer is a digital type, whereas the Spectrum™ Curing Light radiometer is a red light/green light type.
An additional difference in the SPECTRUM™ 800 CURING UNIT from the Spectrum™ Curing Light is the intensity adjustment feature of the light. The operator can dial the intensity of the light. This feature will ensure the operator quality repeat output performance every time the light is used. This feature also allows the operator the ability to match the restoration type with the intensity required.
We believe that the similarity of the SPECTRUM™ 800 CURING UNIT to the predicate device and the performance and safety data provided support the safety and effectiveness of the SPECTRUM™ 800 CURING UNIT for the indicated use.
000022
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of a caduceus, a symbol often associated with healthcare. The caduceus in the logo is composed of three intertwined lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1998
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Requlatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re : K982318 Spectrum 800 Curing Unit Trade Name: Requlatory Class: II Product Code: EBF June 29, 1998 Dated: Received: July 2, 1998
Dear Mr. Lehn:
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 against misbrandinq 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 Requlations, Title 21, Parts 800 to 895. ದ 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 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 - Mr. Lehn
This letter will allow you to beqin 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) 594-4692. 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.fda.gov/cdrh/dsmamain:html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
Device Name:
SPECTRUM™ 800 CURING UNIT
ﺪ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﻨﺘﺠﺎﺕ ﺍﻟ
The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻠﺴ Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Curry
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
00007