(82 days)
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No
The summary describes a light tip for curing composite materials, focusing on physical properties and function (concentrating energy, guiding the beam). There is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is used for curing composite materials in teeth, which is a restorative process to strengthen fillings and reduce gaps, not to treat or cure a disease or medical condition.
No
This device is for curing composite materials, which is a treatment function, not a diagnostic one.
No
The device description and intended use clearly describe a physical "Light Tip" which is a hardware component used for curing composite materials in dental procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device's purpose is to "concentrate the energy and guide the beam to the bottom of the preparation when curing composite materials." This is a physical process used in dental procedures to harden filling materials.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from a patient. Its function is purely related to the application of light energy to a material.
Therefore, the Light Tip, as described, is a dental device used for curing composite materials, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Light Tip is intended to concentrate the energy and guide the beam to the bottom of the preparation when curing composite materials. The deep composite will therefore be cured first which strengthens the filling, creates contact points and reduces the contraction gap.
Product codes
EBZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle's head or a stylized human profile, with three curved lines representing the body or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 02 2002
Ms. Emma Bergquist Product and Ouality Co-ordinator Svenska Dental Instruments AB Finvids Väg 8 P.O. Box 723 SE-194 27 Upplands Väsby SWEDEN
Re: K022265
Trade/Device Name: Light Tip Regulation Number: 872.6475 Regulation Name: Heat Source for Bleaching teeth Regulatory Class: II Product Code: EBZ Dated: July 1, 2002 Received: July 12, 2002
Dear Ms. Bergquist:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Bergquist
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours
Timothy Al Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number:
K022265
Devic : Name:
Indications For Use:
Light Tip
The Light Tip is intended to concentrate the energy and guide the beam to the bottom of the preparation when curing composite materials. The deep composite will therefore be cured first which strengthens the filling, creates contact points and reduces the contraction gap.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K00226
Frescription Us e: (Per 21 )FR 8C 1.109)
OR
Over -the-Counter Use: _
(Optional format 1-2-96)
Svensk > Dentill Instrument AB
P O. Bo: : 723 SIE-194 27 Upp ands Väsby SIVEDE 1
+46-8-506 505 75 Phone No +48-8-506 505 83 Direct line E-mail order and Information E-mail Web site
+46-8-590 306 30 Telefax No VAT-No SE556013882701 info@sdidirecta.com emma.bergquist@sdidirecta.com www.sdidirecta.com