(68 days)
Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.
Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze is offered in different formulations to meet the dental professional: filled, unfilled, very low filler level, no fluoride-releasing. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.
The provided text is a 510(k) Premarket Notification for a dental device called "Pulpdent Glaze." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with acceptance criteria in the way a novel high-risk device might.
Therefore, many of the requested categories regarding acceptance criteria, specific study designs (like MRMC or standalone algorithm studies), sample sizes for test/training sets, and expert-established ground truth are not applicable to this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Pulpdent DenTASTIC UNO, Pulpdent Flows-Rite, UltraDent PermaSeal, UltraDent PermaQuick, Bisco Fortify, Kuraray Clear-Fil SE Bond, Kerr Opti Bond Solo Plus) in design, composition, performance, intended use, safety, and effectiveness. | "PULPDENT GLAZE is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above." |
| Equivalence in Physical and Mechanical Properties to predicate devices. | "laboratory testing has shown that Pulpdent Glaze is equivalent in physical and mechanical properties to the predicate products." |
| No BISPHENOL A content. | "contains no Bisphenol A" |
| Bonds tightly to enamel and composite restorations. | "bonds tightly to enamel and composite restorations" |
| Usable for sealing composite surfaces, margins of restorations, cracks in teeth and restorations, and reducing micro-leakage. | "Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage." |
| Two formulas usable for dentin bonding. | "Two formulas can be used for dentin bonding." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "laboratory testing," but details on sample size for these tests are not provided.
- Data Provenance: Not explicitly stated beyond "laboratory testing." It's implied to be internal testing by Pulpdent Corporation. Retrospective or prospective is not specified, but typically lab testing for predicate equivalence would be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. The ground truth for this type of submission is primarily based on equivalence to predicate devices and established chemical/physical properties rather than a clinical expert consensus on complex outcomes. The "ground truth" for the device's properties would be determined by standard laboratory testing methodologies.
4. Adjudication Method for the Test Set:
- Not Applicable. As described above, this is not a study requiring expert adjudication of results.
5. 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:
- No. This is a dental material, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical dental material, not a software algorithm.
7. The Type of Ground Truth Used:
- The ground truth for demonstrating "safety and effectiveness" and "substantial equivalence" is based on:
- Chemical Composition: Comparison of ingredients to predicate devices.
- Physical and Mechanical Properties: Laboratory test results (e.g., bond strength, filler content, etc.) demonstrating equivalence to predicate devices.
- Intended Use: Alignment with the intended uses of predicate devices.
- Prior Regulatory Findings: The predicate devices themselves having been found substantially equivalent under 510(k) or regulated as Class II devices.
- General Clinical Experience/Scientific Consensus: Reference to the NIH Technology Assessment Conference on Dental Restorative Materials, which broadly states a high benefit-to-risk ratio for such materials over 20 years.
8. The Sample Size for the Training Set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. (See point 8)
{0}------------------------------------------------
APR 1 7 2002
510 k Premarket Notification Pulpdent Glaze
EXHIBIT 2
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
617-926-6666 Telephone: 617-926-6262 Fax: ken@pulpdent.com
DEVICE:
Trade Name: PULPDENT GLAZE Classification Name: Tooth Shade Resin Material FDA Product Code: 76 EBF, 21 CFR Part 872.3690
PREDICATE DEVICES:
Pulpdent DenTASTIC UNO Pulpdent Flows-Rite UltraDent PermaSeal UltraDent PermaQuick Bisco Fortify Kuraray Clear-Fil SE Bond Kerr Opti Bond Solo Plus 3
DESCRIPTION AND INTENDED USE:
Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze is offered in different formulations to meet the dental professional: filled, unfilled, very low filler level, no fluoride-releasing. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.
COMPARISON WITH PREDICATE PRODUCTS:
PULPDENT GLAZE substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.
SAFETY AND EFFECTIVENESS:
PULPDENT GLAZE is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3690 or 872.3200. The chemical ingredients used in Pulpdent Glaze are used in two of the predicate products. Though there is no ISO or ANSI/ADA standard applicable to Pulpdent Glaze, laboratory testing has shown that Pulpdent Glaze is equivalent in physical and mechanical properties to the predicate products.
According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of shortterm or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape and features the department's emblem in the center. The emblem consists of three stylized human profiles facing to the right, with a bird-like shape above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K020432
Trade/Device Name: Pulpdent Glaze Regulation Number: 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Codes: EBD, EBF, and KLE Dated: February 01, 2002 Received: February 08, 2002
Dear Mr. Berk:
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.
{2}------------------------------------------------
Page 2 - Mr. Kenneth J. Berk
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. 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 . Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
INDICATIONS FOR USE STATEMENT
190127 -
510 (k) Number (if known)
PULPDENT GLAZE Device Name
Indications for Use:
Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze is offerent formulations to meet the needs of the dental professional: filled, unfilled, very low filler level, no fluoride and fluoridereleasing. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use v (Per 21 CFR 801.109)
or
Over-The-Counter Use
ﻟﺴﻴﺮ ﺍﻟﻤﺴﺘﻤﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number _
USAN
§ 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.