(35 days)
- Posterior restorative material for Class I, II and V, and composite core build-up.
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.
The provided text describes the predicate device "BISFIL™P" and the applicant device "PYRAMID™", both composite restorative materials. The submission focuses on demonstrating substantial equivalence, primarily through material properties tests rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set) are not applicable or cannot be extracted from the given text.
Here's an analysis of the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (PYRAMID™) | Performance (Predicate Device: BISFIL™P) |
|---|---|---|
| Diametral Tensile Strength (DTS) | 51 MPa | 55 MPa |
| Biocompatibility | Non-toxic (Cytotoxicity per ISO 10993-5) | (Implied compliant as predicate) |
| Wear Resistance | "more wear resistance" (compared to general expectation for composites needing reinforcement) | "vastly improved abrasive resistance" |
| Tensile Strength | "higher tensile strength" (compared to general expectation for composites needing reinforcement) | "high tensile strength" |
| Compressive Strength | "higher compressive strength" (compared to general expectation for composites needing reinforcement) | "high compressive strength" |
| Radiopacity | Radiopaque | Radiopaque |
| Filler Content | 79% w/w | 86% w/w |
| Consistency/Handling | Condensable, similar to conventional amalgam | Condensable, similar to conventional amalgam |
Note on Acceptance Criteria: The document primarily states that PYRAMID's physical properties are "similar to the predicate device" and are designed to be "more wear resistance as well as higher tensile and compressive strength" (in a general sense of desirable properties for posterior composites). The only specific numerical acceptance criterion implied by direct comparison is the DTS value being close enough to the predicate to establish substantial equivalence.
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the DTS test.
- Data Provenance: The document refers to "non-clinical tests" and standards like ISO 4049 and American Dental Association #27. Cytotoxicity testing was performed by a "commercial testing laboratory (NAMSA)". No country of origin for the data is explicitly mentioned beyond the US location of the applicant. The data is retrospective in the sense that the tests were performed on the materials after their development to demonstrate equivalence.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a materials property study, not a clinical study requiring expert ground truth for diagnostic accuracy.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Not a diagnostic study requiring adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance described is for the material itself in laboratory settings.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For the physical properties, the "ground truth" is the measured value from standardized non-clinical tests (e.g., DTS per ISO standards). For biocompatibility, it's the official report from the commercial testing laboratory based on ISO 10993-5.
-
The sample size for the training set:
- Not applicable. This is a material, not a machine learning model.
-
How the ground truth for the training set was established:
- Not applicable. This is a material, not a machine learning model.
{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
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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
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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)
§ 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.