(35 days)
- Direct or indirect class 1, II, III, IV, V, and VI restorations.
- Core build-up material to replace missing tooth structure.
- Composite restorations bonded to tooth structure.
- Composite restorations bonded to metal.
- Composite restorations bonded to composite or fiber-reinforced substructure.
- Composite restorations bonded to porcelain.
The ADVENT™ system is comprised of a Dentin component and an Enamel component. ADVENT Dentin is a highly filled (78.6% w/w) composite designed for class I. II. III. IV. V. and VI restorations and composite core build-up. ADVENT™ Enamel is a highly filled composite which, like belleGlas™ Enamel, is designed for high resistance to wear and abrasion as well as good polishability. Both Dentin and Enamel components are radiopaque and polymerizable by a dual cure system (heat/light), i.e., can be light cured by conventional means or processed in a dedicated curing device that employs heat and light in a pressurized, oxygen-free nitrogen atmosphere. The ADVENT™ system is designed to be used with high quality dentin/enamel adhesive systems.
This submission pertains to the ADVENT™ dental composite system. The acceptance criteria and supporting study details are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Property) | Acceptance Criteria (Predicate) | Reported Device Performance (ADVENT™) |
|---|---|---|
| Diametral Tensile Strength (DTS) - Dentin | 63 MPa (belleGlas™ Dentin) | 65 MPa (ADVENT™ Dentin) |
| Diametral Tensile Strength (DTS) - Enamel | 57 MPa (belleGlas™ Enamel) | 55 MPa (ADVENT™ Enamel) |
| Biocompatibility (Cytotoxicity) | Non-toxic (belleGlas™ HP) | Non-toxic (ADVENT™) |
| Wear Resistance | High (belleGlas™ HP) | High (ADVENT™) |
| Tensile Strength (General) | Increased (belleGlas™ HP) | Increased (ADVENT™) |
| Compressive Strength | Increased (belleGlas™ HP) | Increased (ADVENT™) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the Diametral Tensile Strength (DTS) tests. It refers to ISO 4049 and American Dental Association #27 for dental resin-based filling materials, which would typically define such sample sizes. The data appears to be retrospective, comparing the new device ADVENT™ with the legally marketed predicate device belleGlas™ HP, and seems to originate from internal BISCO, INC. testing. No country of origin for the specific test data is provided beyond the company's location in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device's performance is based on standardized physical and mechanical property testing (DTS, wear resistance, strength) and biocompatibility testing, not on expert interpretations of clinical cases or images.
4. Adjudication method for the test set
Not applicable. This is not a clinical study involving human assessment of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on physical, mechanical, and biocompatibility properties rather than clinical outcomes assessed by multiple readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies performed (Diametral Tensile Strength and Biocompatibility (cytotoxicity)) are standalone tests of the material properties, without any human-in-the-loop component for performance evaluation.
7. The type of ground truth used
The ground truth used is based on:
- Standardized Physical and Mechanical Property Measurements: Diametral tensile strength (DTS) and general assertions of wear resistance, tensile strength, and compressive strength, likely measured per ISO 4049 and ADA #27.
- Biocompatibility Testing: Specifically, cytotoxicity, tested per ISO 10993-5.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The device is a dental composite material.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 510(k) Submission for ADVENT™
SUMMARY
Leqally Marketed Predicate Device belleGlas™ HP
The belleGlas™ HP system includes a Dentin and Enamel component. The Dentin component is engineered for high physical and mechanical strength and the Enamel component is formulated for high resistance to wear and abrasion. Both components are highly filled, radiopaque composites designed for indirect restorations. The belleGlas™ HP composites are cured by light, heat, and pressure in a dedicated device.
Description of A plicant Device ADVENT™
The ADVENT™ system is also comprised of a Dentin component and an Enamel component. ADVENT Dentin is a highly filled (78.6% w/w) composite designed for class I. II. III. IV. V. and \1 restorations and composite core build-up. ADVENT™ Enamel is a highly filled composite which, like belleGlas™ Enamel, is designed for high resistance to wear and abrasion as well as good polishability. Both Dentin and Enamel components are radiopaque and pclymerizable by a dual cure system (heat/light), i.e., can be light cured by conventional mear s or processed in a dedicated curing device that employs heat and light in a pressurized, cxvaen-free nitrogen atmosphere. The ADVENT™ system is designed to be used with hich quality dentin/enamel adhesive systems.
Intended Uses of Applicant Device ADVENTTM
ADVENT™ is intended for direct or indirect class I, II, III, IV, V, and VI restorations and composite core build-up. ADVENT™ is also intended for composite restorations bonded to tooth structure, metal, composite, fiber-reinforced substructure, and porcelain.
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Scientific Conce its and Significant Performance Characteristics
The ADVENT™ and belleGlas™ HP systems are very similar with regard to chemical composition and selected physical/mechanical properties. Significantly, belleGlas™ HP and ADVENT™, following curing, have been designed to have increased wear resistance, tensile strength, and compressive strenath. These properties are essential to a composite in order for it to function effectively. The highly viscous nature of belleGlas™ HP and ADVENT™ allows them to be easily sculpted and shaped.
The chemical compositions of belleGlas™ HP and ADVENT™ are quite similar. Both are silica and glass fillers dimethacrylate hybrid composites. Both can be cured by heat, light, and pressure in dedicated devices.
The non-clinical tes s used for this submission are similar to those specified in ISO 4049 and American Dential Association #27: both are for dental resin based filling materials. Diametrial tensile strength (DTS) is an accepted method to characterize the tensile strength of trittle materials. DTS of ADVENT™ Dentin and belleGlas™ Dentin are, respectively, 65 and 63 MPa. DTS of ADVENT™ Enamel and belleGlas™ Enamel are, respectively, 55 and 57 MPa.
Biocompatibility of ADVENT™, cytotoxicity, was performed per ISO 10993-5 by a commercial testing laboratory (NAMSA) and the product was found to be non-toxic.
Comparison of ADVENT™ to the predicate device illustrates that the two items are very similar. The major difference between the two systems is in the intended uses. ADVENT™ may be used for direct as well as indirect restorations. The predicate device is designed specifically for direct restorations only.
Steven J. Durav. Ph.D. Manager of Technical Business Support Services 1-800-BIS-DENT or 1847) 534-6094 FAX: (847) 891-6705 November 16, 1998
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BISCO, INC., 1100 V. Irving Park Road, Schaumburg, IL 60193 510(k) Submission fc r ADVENT™
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REFERENCES
: 上一篇:
... .
- International Standards Organization, ISO 4049:1988/Cor. 1:1992 (E), Resin S 1. Based Filling Materials, 1992.
- BISCO, INC. Quality Control Procedures, QC-0003, 1987. 2.
- ibid. QC-00C 4. 3.
- ibid. QC-00C 6. 4.
- Craig, R. G. (ed.), Restorative Dental Materials, eighth edition, C. V. Mosby Co., 5. St. Louis, 1589, p 277.
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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 consists of a stylized graphic of three abstract shapes resembling birds in flight, positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1998
Steven J. Duray, Ph.D. Manager of Technical Business Support Services BISCO, Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193
Re: K984112 ADVENT™ Trade Name: Regulatory Class: II Product Code: EBF Dated: November 16, 1998 Received: November 17, 1998
Dear Dr. Duray:
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. ਖ 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 regulatory In addition, FDA may publish further announcements action. 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. Duray
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 regulation 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
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 510(k) Submission for ADVENT™
INDICATIONS FOR USE
| 510(k) Number (if known): | K984112 |
|---|---|
| --------------------------- | --------- |
Device Name: ADVE:NT™
Indications for Use:
- Direct or indirect class 1, II, III, IV, V, and VI restorations. 1.
- Core build-up material to replace missing tooth structure. 2.
- Composite restorations bonded to tooth structure. 3.
- Composite restorations bonded to metal. 4.
- fiber-reinforced ട. Composite restorations bonded to composite or substructure.
- Composite restorations bonded to porcelain. 6.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)
× Prescription for Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
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§ 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.