(35 days)
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No
The description details a simple warming device with a heating element and temperature control circuit, with no mention of AI or ML terms or functionalities.
No.
The device is used to warm dental materials and anesthetic carpules for preparation, not for direct therapeutic treatment of a disease or condition.
No
Explanation: The device description states that the Calset unit is used to warm dental composite materials, whitening bleach, and anesthetic carpules. It is a warming device and does not appear to diagnose any condition or disease.
No
The device description explicitly states it consists of hardware components such as a base unit, heating element, temperature control circuit, metal tray, and wall transformer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to warm dental materials (composite, whitening bleach, anesthetic carpules) prior to their use in the mouth. This is a preparation step for materials that will be used in vivo (within the body), not for testing samples in vitro (outside the body).
- Device Description: The description details a warming device for dental materials, not a device designed to analyze biological samples or perform diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing diagnostic tests, or providing information about a patient's health status based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely to warm materials for dental procedures.
N/A
Intended Use / Indications for Use
Intended Use: The Calset unit is used to warm dental composite materials and whitening bleach to130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).
Product codes (comma separated list FDA assigned to the subject device)
EBZ, EFC, and EEG
Device Description
The Calset is a warming device used to heat dental materials prior to their use in the mouth. It consists of a base unit that contains a heating element a temperature control circuit with LED indicators, a removable metal tray that is designed to hold different materials and a low voltage wall transformer that provides power to the unit.
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): 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.
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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.
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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).
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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.
0
Image /page/0/Picture/0 description: The image shows the text "JUN 2 3 2006" on the top left and "K06 1395" on the top right. Below the date is the word "ADDENT" with the text "510(k) SUMMARY" below it. The text is black and the background is white.
Submitters Name: Joshua Friedman, D.D.S
Address: AdDent, Inc 43 Miry Brook Rd. Danbury, CT 06810
Phone: (203) 778-0200
Fax: (203) 792-2275
Device Name: Calset Composite Heater
Common Name: Composite Warmer
Classification Name: Not officially classified
Marketed Device of Equivalence: Aesthetic Warmer. Product code EFC, regulation number 872.6100 (exempt).
Description of the Device:
The Calset is a warming device used to heat dental materials prior to their use in the mouth. It consists of a base unit that contains a heating element a temperature control circuit with LED indicators, a removable metal tray that is designed to hold different materials and a low voltage wall transformer that provides power to the unit.
Intended Use: The Calset unit is used to warm dental composite materials to 130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).
Characteristics of the Calset Compared to Predicate Device: Both the Calset and the Anesthetic Warmer heat material that are in contact with the patient. The SE device heats anesthetic solution to body temperature (98°F). The Calset has three temperature settings 98°F (37°C), 130°F (54°C) or 155°F (68°C). The 98°F setting on the Calset is used together with a removable metal tray that holds anesthetic carpules.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2006
Joshua Friedman, DDS President AdDent, Incorporated 43 Miry Brook Road Danbury, Connecticut 06810
Re: K061395
Trade/Device Name: Calset Composite Heater Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ, EFC, and EEG Dated: May 17, 2006 Received: May 24, 2006
Dear Dr. Friedman:
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 - Joshua Friedman, DDS
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
KO 61395
510(k) Number (if known):
Device Name: Calset Composite Heater
Indications for Use:
Intended Use: The Calset unit is used to warm dental composite materials and whitening bleach to130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Su
Concurrence of CDRH, Office of Device Evaluation (ODE)
Don Sign-Off)
on of Anesthesiology, General Hospital,
dion Control, Dental Devices
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