(35 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and mechanical strength of a dental composite, with no mention of AI or ML technologies.
No.
Explanation: The device is described as a "restorative material" (composite) for dental use, which is used to fill cavities and build up tooth structure, rather than to treat a specific disease or condition. Its function is to restore the physical integrity of the tooth.
No
The device is described as a "Posterior restorative material" and a "condensable, highly filled...light-cured radiopaque composite," indicating it is a material used for treatment (restoration) rather than diagnosis. Its physical properties and performance studies characterize its strength and biocompatibility, not its ability to detect or identify a condition.
No
The device description clearly states it is a "condensable, highly filled...light-cured radiopague composite," which is a physical material, not software. The performance studies also focus on material properties like tensile strength and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Posterior restorative material for Class I, II and V, and composite core build-up." This describes a material used in the body for dental restoration, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a "condensable, highly filled... light-cured radiopague composite." This is a material used for filling cavities and building up tooth structure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Posterior restorative material for Class I, II and V, and composite core build-up.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
PYRAMID is a condensable, highly filled (79% w/w), light-cured radiopague composite. Its physical properties are similar to the predicate device and uses are identical. Like the predicate device, PYRAMID is glass frit filled dimethacrylate composite. It hardens by light cure polymerization mechanism employing light initiators. Both devices are designed to be used with high quality dentin / enamel adhesive systems.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association #27; both are for dental resin based filling materials. Diametral tensile testing (DTS) is an accepted method to characterize the tensile strength of brittle materials and the flexural modulus test addresses the strength in three point loading. DTS values are 55 and 51 MPa for BISFIL P and PYRAMID respectively.
Biocompatability of PYRAMID, Cytotoxicity, was performed per ISO 10993-5 by a commercial testing laboratory (NAMSA) and the product was found to be non-toxic.
Side by side comparisons of PYRAMID to the predicate device provided in this submission (page 11) clearly demonstrated that the applicant device, PYRAMID, is substantially equivalent to the legally marketed predicate device, BISFIL P.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DTS values are 55 and 51 MPa for BISFIL P and PYRAMID respectively.
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.
Not Found
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
2 1998
510(k) Submission for PYRAMID™ BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193
SH 22 of 25
510(k) SUMMA
As Required by 21 CFR 807.93
APPLICANT DEVICE Trade Name: PYRAMID™ Common Name: Composite Restorative Material Classification Name: Tooth Shade Resin Material, Class II, 21 CFR 872.3690
LEGALLY MARKETED PREDICATE DEVICE: BISFIL™P
PREDICATE DEVICE BISFIL P
BISFIL P is a high viscosity, light cure hybrid composite restorative material. It is a highly filled (86% w/w), radiopaque, condensable composite designed for restoration of posterior primary and permanent teeth. The high filler concentration results in vastly improved abrasive resistance as well as high tensile and compressive strength. Condensable BISFIL P bonds micromechanically and chemically to dental primers/bonding resin adhesives through co-polymerization of the former's air inhibited layer. The material is radiopaque for easy radiographic identification and evaluation. BISFIL P is designed to be marketed as a stand alone product.
DESCRIPTION OF APPLICANT DEVICE PYRAMID
PYRAMID is a condensable, highly filled (79% w/w), light-cured radiopague composite. lts physical properties are similar to the predicate device and uses are identical. Like the predicate device, PYRAMID is glass frit filled dimethacrylate composite. It hardens by light cure polymerization mechanism employing light initiators. Both devices are designed to be used with high quality dentin / enamel adhesive systems.
INTENDED USES OF APPLICANT DEVICE PYRAMID
PYRAMID is indicated for: posterior restorative material for Class I, II and V, and composite core build-up restoration
1
510(k) Submission for PYRAMID™ BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193
SH 23 of 25
510(k) SUMMARY (cont.)
SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS
BISFIL P and PYRAMID are very similar with regard to chemical composition and selected physical/mechanical properties. Significantly, BISFIL P and PYRAMID, following curing, have been designed to be more wear resistance as well as higher tensile and compressive strength. These properties are essential for composite to function effectively in the posterior segments. The highly viscous nature of BISFIL P and PYRAMID allows them to handle similar to conventional amalgam. Their condensability" provides ease in establishing occlusal contours, proximal surfaces and interproximal contacts.
The chemical compositions of BISFIL P and PYRAMID are quite similar. Both are silica and glass filled methacrylate light-cure hybrid composites.
The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association #27; both are for dental resin based filling materials. Diametral tensile testing (DTS) is an accepted method to characterize the tensile strength of brittle materials and the flexural modulus test addresses the strength in three point loading. DTS values are 55 and 51 MPa for BISFIL P and PYRAMID respectively.
Biocompatability of PYRAMID, Cytotoxicity, was performed per ISO 10993-5 by a commercial testing laboratory (NAMSA) and the product was found to be non-toxic.
Side by side comparisons of PYRAMID to the predicate device provided in this submission (page 11) clearly demonstrated that the applicant device, PYRAMID, is substantially equivalent to the legally marketed predicate device, BISFIL P.
Y. Joung
Kathy Joung, Ph.D. QA/QC Manager 1-800-BIS-DENT or 847-534-6106 Fax: 847-891-6865 July 24, 1998
2
510(k) Submission for PYRAMID™ BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193
SH 24 of 25
REFERENCES
- Craig, R. G. (ed), Restorative Dental Materials, eighth edition, C. V. 1. Mosby Co., St. Louis, 1989, p 277.
- International Standards Organization, ISO 4049:1988/Cor. 1:1992 (E), 2. Resin Based Filling Materials, 1992.
- Bisco, Inc. Quality Control Procedures, QC-0004, 1987. 3.
- ibid. QC-003, 1998 4.
-
- ibid. QC-006, 1997
3
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a stylized eagle above the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 SFB
Kathy Jounq, Ph.D. QA/QC Manager BISCO, Incorporated 1100 West Irving Park Road Schaumburq, Illinois 60193
Re : K982645 PYRAMID™ Trade Name: Requlatory Class: II Product Code: EBF Dated: July 24, 1998 July 29, 1998 Received:
Dear Dr. Young:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
4
Page 2 - Dr. Young
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
S. Dietman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Submission for PYRAMID™ BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193
SH 10 of 25
INDICATIONS for USE
510(k) Number (if known): K-- 982645
Device Name: _PYRAMID™
Indications for Use:
- Posterior restorative material for Class I, II and V, and composite core build-up.
Susan Ruann
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRL, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)