(161 days)
Used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth; as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root canes lesions; and for core build-up
DYRACT® AP RESTORATIVE is a one-component, visible light curing, dental restorative material, delivered in COMPULES®, which hardens upon polymentation. The composition is polymenzed by brief exposure to visible light from a dental curing light. When polymenzation occurs, the monomers cross-link to form polymer-containing carboxyl groups which are capable of further reaction with cations eluted from the glass-reinforcing filler to form a salt, as in DYRACT® II Restorative (K950991). The modifications to the DYRACT II Restorative serve to enhance the strength and wear resistance of DYRACT AP RESTORATIVE.
This document is a 510(k) Summary for a dental restorative material, not a study evaluating a device using "acceptance criteria" in the typical sense of statistical performance metrics. It's a premarket notification for a Class II medical device (DYRACT® AP RESTORATIVE) to demonstrate substantial equivalence to a predicate device (DYRACT® II Restorative).
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not applicable to the format and content of a 510(k) summary focused on substantial equivalence based on material properties and intended use.
However, I can provide information based on what is present in the document.
Summary based on the provided document:
The document describes DYRACT® AP RESTORATIVE, a one-component, visible light-curing, dental restorative material. The core of the submission is to demonstrate its substantial equivalence to a predicate device, DYRACT® II Restorative (K950991). The modifications to the DYRACT® II Restorative "serve to enhance the strength and wear resistance of DYRACT AP RESTORATIVE."
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in terms of statistical thresholds for clinical performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on the similarity of physical properties and safety testing to establish substantial equivalence.
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical Properties | Similar to the predicate device (DYRACT® II Restorative) | "The physical properties of DYRACT AP RESTORATIVE and the predicate device are similar." (No specific values or metrics are provided in this summary, but this is the claim made to demonstrate equivalence). The modifications enhance strength and wear resistance, implying improvement while maintaining overall similarity. |
| Biocompatibility/Safety | Non-mutagenic and non-sensitizing | Cured material was tested by the Ames Mutagenicity Test and Guinea Pig Sensitization Test. The cured material is reported as non-mutagenic and a non-sensitizer. |
| Components | Components have been used in legally marketed devices or found safe for dental use. | "All components in DYRACT AP RESTORATIVE have been used in legally marketed devices or found to be safe for dental use." |
| Intended Use | Same as or similar to the predicate device, for specific dental restorative applications. | Stated intended uses: permanent restorative in all cavity classes (permanent & deciduous teeth), base material, laminate/open sandwich, root caries, core build-up. (No direct comparison to predicate intended use provided in this summary, but implied to be equivalent or enhanced). |
2. Sample Size for Test Set and Data Provenance:
The document does not describe a "test set" in the context of diagnostic or AI device evaluation. It is referring to material property testing and safety testing.
- Sample Size: Not specified for physical property comparisons or for the Ames Mutagenicity Test and Guinea Pig Sensitization Test.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for material science testing.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This is not a study requiring expert readers or ground truth establishment in a clinical imaging context. The evaluation is focused on material properties and safety.
4. Adjudication Method:
Not applicable. This is not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a study involving human readers or AI assistance in a diagnostic context.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a dental material, not an algorithm or software device.
7. Type of Ground Truth Used:
Ground truth in this context would implicitly be laboratory measurements for physical properties (e.g., strength, wear resistance) and validated biological assays for safety (Ames test, sensitization test). No clinical "ground truth" (e.g., pathology, outcomes data) is mentioned in this summary as the basis for performance evaluation, as the device is not a diagnostic tool requiring such validation.
8. Sample Size for the Training Set:
Not applicable. This is a dental material; there is no "training set" as understood in machine learning or AI.
9. How Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this device.
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510(k) SUMMARY
Image /page/0/Picture/2 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and appear to be in black. The font is stylized, with some letters having sharp angles and cutouts. The overall impression is of a strong, established brand name.
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fox 171718542343
P. J. Lehn Telefax (717) 849-4343
| CONTACT: | P. Jeffery Lehn | |
|---|---|---|
| DATE PREPARED: | August 27, 1997 | |
| TRADE OR PROPRIETARY NAME: | DYRACT® AP RESTORATIVE | |
| CLASSIFICATION NAME: | Tooth resin shade material | 872.3690 |
| PREDICATE DEVICE: | DYRACT® II Restorative | K950991 |
DYRACT® AP RESTORATIVE is a one-component, visible light DEVICE DESCRIPTION: curing, dental restorative material, delivered in COMPULES®, which hardens upon polymentation. The composition is polymenzed by brief exposure to visible light from a dental curing light. When polymenzation occurs, the monomers cross-link to form polymer-containing carboxyl groups which are capable of further reaction with cations eluted from the glass-reinforcing filler to form a salt, as in DYRACT® II Restorative (K950991). The modifications to the DYRACT II Restorative serve to enhance the strength and wear resistance of DYRACT AP RESTORATIVE.
The physical properties of DYRACT AP RESTORATIVE and the predicate device are similar.
INTENDED USE: DYRACT AP RESTORATIVE is used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth: as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root caries lesions: and for core build-up.
TECHNOLOGICAL CHARACTERISTICS: All components in DYRACT AP RESTORATIVE have been used in legally marketed devices or found to be safe for dental use.
DYRACT AP RESTORATIVE (cured material) was tested by the Ames Mutagenicity Test and Guinea Pig Sensitization Test. The cured material is non-mutagenic and a non-sensitizer.
We believe that the prior use of the components of DYRACT AP RESTORATIVE in legally marketed predicate devices, the results of the toxicity and sensitization testing, and the performance data support the safety and effectiveness of DYRACT AP RESTORATIVE for the indicated uses.
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, one behind the other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 1998
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405
K973235 Re : DYRACT® AP RESTORATIVE Trade Name: Regulatory Class: II Product Code: EBF January 28, 1998 Dated: January 30, 1998 Received:
Dear Mr. Lehn:
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 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 The general controls provisions of the Act 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 - Mr. Lehn
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
Device Name:
DYRACT® AP RESTORATIVE
Indications for Use:
Used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth; as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root canes lesions; and for core build-up
Concurence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices K973233
Prescription Use
OR
Over-The-Counter Use
000007
§ 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.