(52 days)
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Not Found
No
The summary describes a dental composite material and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a restorative material used to fill cavities, which is a structural repair rather than a therapeutic treatment.
No
The device description states that Premise is a dental composite restorative material, meaning it is used for treatment (restoration of cavities), not for diagnosing conditions.
No
The device description clearly states it is a "light cured resin based composite dental restorative," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a dental composite restorative material intended to be used in all classes of cavites." This describes a material used directly on the patient for restoration, not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description details a "light cured resin based composite dental restorative designed for direct placement." This further reinforces its use as a material applied directly to the tooth.
- Lack of IVD Characteristics: The description 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.
Therefore, this device falls under the category of a dental restorative material used for direct treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Premise is for use in all classes of cavities.
Premise is a dental composite restorative material intended to be used in all classes of cavites.
Product codes
EBF
Device Description
The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.
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
Not Found
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.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the text "K032921" in the upper left corner, followed by the logo for "sds" in the upper right. Below the logo is the text "SYBRON, DENTAL SPECIALTIES". The bottom of the image contains the text "Section III - 510(k) Summary of Safety and Effectiveness".
NOV 1 3 2003
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: September 2003
Device Name:
- Trade Name Premise ●
- Common Name - Dental Composite Restorative Material
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 ●
Devices for Which Substantial Equivalence is Claimed:
- Kerr Dental Materials Center, Point 4 Modified ●
Device Description:
The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.
Intended Use of the Device:
The intended use of Premise is for use in all classes of cavities.
Substantial Equivalence:
Premise is substantially equivalent to other legally marketed devices in the United States. Premise functions in a manner similar to and is intended for the same use as Point 4 Modified that is currently marketed by Kerr Dental Materials Center.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three wavy lines below them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2003
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K032921
Trade/Device Name: Premise Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 15, 2003 Received: September 22, 2003
Dear Ms. Boswell:
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. Colleen Boswell
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 (OS) 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 (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) you may obtain. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Oup
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
510(k) Number (if known):____K032921
Device Name: Premise
Indications For Use:
Premise is a dental composite restorative material intended to be used in all classes of cavites.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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