(88 days)
Not Found
Not Found
No
The summary describes a dental composite material and its physical properties, with no mention of AI or ML.
No
The device is a dental restorative material used to fill cavities, which is a structural repair rather than a therapeutic treatment for disease.
No
The device is described as a restorative material used for filling cavities, not for diagnosing conditions.
No
The device is a physical dental restorative 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 clearly states it's a "dental composite restorative material intended to be used in all classes of cavities." This describes a material used directly on the patient for treatment, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the composition and properties of a dental filling material. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document lacks any information typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Diagnostic claims
- Mention of assays, reagents, or laboratory procedures
Therefore, this device is a medical device, specifically a dental restorative material, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Point 4 Modified is a dental composite restorative material intended to be used in all classes of cavities
Product codes
EBF
Device Description
The device is a micro-hybrid light cured resin-based dental restorative which contains approximately 79% by weight (59% by volume) inorganic filler but with a particle size nearly half that of Kerr's Herculite XRV and Prodigy. This breakthrough in filler technology provides a higher, longer-lasting polish similar to a microfill, without any negative effects to the physical properties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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.
0
JAN 1 8 2002
Image /page/0/Picture/1 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.
Section III - 510(k) Summary of Safety and Effectiveness
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: October 2001
Device Name:
- Trade Name Point 4 Modified .
- 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 Corporation, Prodigy 4 .
Device Description:
The device is a micro-hybrid light cured resin-based dental restorative which contains approximately 79% by weight (59% by volume) inorganic filler but with a particle size nearly half that of Kerr's Herculite XRV and Prodigy. This breakthrough in filler technology provides a higher, longer-lasting polish similar to a microfill, without any negative effects to the physical properties.
Intended Use of the Device:
The intended use of Point 4 Modified is for use in all classes of cavities.
Substantial Equivalence:
Point 4 Modified is substantially equivalent to other legally marketed devices in the United States. The dental 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 Dental Materials Center.
1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN 1 8 2002
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K013510
Trade/Device Name: Point 4 Modified Regulation Number: 872.3690 Regulation Name: Dental Composite Restorative Material Regulatory Class: II Product Code: EBF Dated: October 18, 2001 Received: October 22, 2001
Dear Ms. Boswell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your end 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 Intender conmiser or proces 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 approvisions 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 (1 will), it may be back of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.
2
Page 2 - Ms. Boswell
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.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Kildaloruh
Timot A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I
Indications for Use Statement
Ver/ 3 - 4/24/96
Applicant: Kerr Dental Material Center
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K013510 |
| Device Name: | Point 4 Modified |
Indications For Use:
Point 4 Modified is a dental composite restorative material intended to be used in all classes of cavities
| Labels | Values |
|---|---|
| (k) Number | K013510 |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)