(64 days)
Kerr Corporation, Point 4 Flowable
Not Found
No
The 510(k) summary describes a dental restorative material and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a restorative dental material used for filling teeth and other dental procedures, not for treating a disease or condition in the conventional sense of a therapeutic device.
No
Explanation: The device is a dental restorative material used for repairing teeth and other dental structures, not for diagnosing conditions. Its intended uses involve treatment and restoration, not diagnostic assessment.
No
The device description clearly states it is a "nano-filled, light-cure, resin restorative material dispensed in a syringe with single-use tips," indicating it is a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material used for restoring and repairing teeth within the patient's mouth (in vivo). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a dental restorative material applied directly to the tooth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, Premise Flowable is a dental restorative material, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of Premise Flowable is for use as a filling material for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in nonstress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
Premise Flowable is a nano-filled, light cure, resin dental restorative suitable for Class I -I remise i towable to a natio introl, togner include: base/liner material, repair of enamel v Testorations. Additional ransitions informers in restorations, minor occlusal build-ups in detects, repar of temporaries, repair vs pear vs peramic/composite veneers, incisal abrasions, and core build-ups.
Product codes
EBF
Device Description
Premise Flowable is a nano-filled, light-cure, resin restorative material dispensed in a syringe with single-use tips. Premise Flowable uses pre-polymerized filler and nanofillers combined with proven Point 4 technology to deliver strength and durability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Kerr Corporation, Point 4 Flowable
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized font, with a curved line above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are written in a simple, sans-serif font. The logo is black and white.
APR 2 8 2006
Image /page/0/Picture/2 description: The image contains a sequence of handwritten digits and letters. The sequence starts with the letter 'K', followed by the numbers '060472'. The characters are written in black ink on a white background and appear to be part of a code or identification number.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person
February 2006 Date Summary Prepared:
Device Name:
- Trade Name Premise Flowable ◆
- Common Name Light-Curable Dental Restorative Material .
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, Point 4 Flowable .
Device Description:
Premise Flowable is a nano-filled, light-cure, resin restorative material dispensed in a syringe with single-use tips. Premise Flowable uses pre-polymerized filler and nanofillers combined with proven Point 4 technology to deliver strength and durability.
Intended Use of the Device:
The intended use of Premise Flowable is for use as a filling material for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in nonstress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
Substantial Equivalence:
Premise Flowable is substantially equivalent to other legally marketed devices in the United States. The composite restorative material marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Corporation.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the seal is an abstract symbol resembling an eagle or bird with three stylized lines representing wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kerr Corporation C/O Ms. Colleen Boswell Sybron Dental Specialties 100 Bayview Circle Suite 6000 Newport Beach, California 92660
APR 2 8 2006
Re: K060472
Trade/Device Name: Premise Flowable Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 22, 2006 Received: February 23, 2006
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 (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" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I
Indications for Use
K060472 510(k) Number (if known):
Device Name: Premise Flowable
Indications For Use:
Premise Flowable is a nano-filled, light cure, resin dental restorative suitable for Class I -I remise i towable to a natio introl, togner include: base/liner material, repair of enamel v Testorations. Additional ransitions informers in restorations, minor occlusal build-ups in detects, repar of temporaries, repair vs pear vs peramic/composite veneers, incisal abrasions, and core build-ups.
Prescription Use ✓
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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) -11-21 11 0
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logy, General Hospi
.t.d Dental Devices