(78 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, which is used to fill cavities in teeth, rather than to treat a disease or condition therapeutically.
No
Explanation: The device is described as a dental composite restorative material, which is used for repairing teeth, not for diagnosing conditions.
No
The device description clearly states it is a dental composite restorative material, which is a physical substance, 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 in the body to restore tooth structure, not a test performed on a sample taken from the body 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 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 diagnostic information about a patient's health status
Therefore, the Point 4 Translucent Modified is a medical device, but specifically a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Point 4 Translucent Modified is for use in all classes of cavities.
Point 4 Translucent Modified is a dental composite restorative material intended to be used in all classes of cavities
Product codes (comma separated list FDA assigned to the subject device)
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
all classes of cavities
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): 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.
Kerr Corporation, Prodigy 4 Translucent Shades
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.
Not Found
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).
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
4013529
sds
SYBRON DENTAL SPECIALTIES
JAN 0 9 2002
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 Translucent 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 Translucent Shades .
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 Translucent Modified is for use in all classes of cavities.
Substantial Equivalence:
Point 4 Translucent 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.
1
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
JAN 0 9 2002
Re: K013529
Trade/Device Name: Point 4 Translucent Modified Regulation Number: 872.3690 Regulation Name: Dental Composite Restorative Material Regulatory Class: II Product Code: EBF Dated: October 18, 2001 Received: October 23, 2001
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.
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.
Timothy 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 |
|---|---|
| 510(k) Number (if known): | K013529 |
| Device Name: | Point 4 Translucent Modified |
| Indications For Use: |
Point 4 Translucent Modified is a dental composite restorative material intended to be used in all classes of cavities
Susan Humon
(Division Sign-Off)
Division of Dental, Infection Control,
General Hospital Devices
| Number | K018309 |
|---|---|
| -------- | --------- |
(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)