PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass lonomer Cement is used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations and as a base and liner under restorations. It combines the advantages of a glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ Paste is a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form. It is not recommended for post cementation or veneer cementation.

Device Description

PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass Ionomer Cement is used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations and as a base and liner under restorations. It combines the advantages of a glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ Paste / Paste is a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form. It is not recommended for post cementation or veneer cementation.

AI/ML Overview

This document (K030036) is a 510(k) premarket notification for a dental device, Pulpdent Triple-Cure™ Paste/Paste Resin Reinforced Glass Ionomer Cement. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of typical AI/medical device performance evaluation.

Here's why and what information is available:

Type of Device: This is a physical dental cement, not an AI/software as a medical device (SaMD). The evaluation process for physical materials like dental cements focuses on material properties, biocompatibility, and substantial equivalence to existing products.
Regulatory Pathway: The 510(k) pathway (Premarket Notification) is used for devices that are substantially equivalent to existing legally marketed devices. This means the primary evidence required is a comparison to predicates, not a de novo study with acceptance criteria for novel performance.
"Safety and Effectiveness" Section: The document references the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, which states: "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States." This is a general statement about the class of materials, not specific acceptance criteria or performance metrics for this particular device. It's used to support the overall safety of the material type.

Based on the provided text, I cannot complete the requested tables and information about acceptance criteria and a study to prove they are met because such a study, with specific acceptance criteria and performance metrics (like sensitivity, specificity, etc.), is not part of this 510(k) submission.

However, I can extract the relevant information about the device and its regulatory context:

Device Information:

Trade Name: PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass Ionomer Cement
Classification Name: Adhesive, Bracket and Tooth Conditioner, Resin
FDA Product Code: DYH, 21 CFR Part 872.3750 (also EMA listed later in the letter)
Intended Use: Used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations, and as a base and liner under restorations. It's a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form.
Not Recommended for: Post cementation or veneer cementation.
Predicate Devices:
- Pulpdent Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement (This appears to be an earlier version or related product by the same company)
- GC Fuji Ortho LC (light-cure)
- GC Fuji Ortho Self-cure
- Pulpdent Band-Rite

The core of this submission is the "Comparison with Predicate Products," which states: "PULPDENT Triple Cure Paste / Paste is substantially equivalent in composition and intended use to the predicate products listed above. Please see Exhibit 4 for the entire comparison." (Exhibit 4 is not provided in the input text).

Conclusion:

This document is a formal FDA communication regarding a 510(k) clearance for a physical dental cement. It demonstrates substantial equivalence to existing predicate devices, focusing on composition and intended use rather than presenting performance data against specific acceptance criteria in the manner one would for a novel AI/SaMD.

Summary

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Pulpdent Triple-Cure™ Paste/Paste Resin Reinforced Glass Ionomer Cement

EXHIBIT 2

2030036

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

MAR 1 2 2003

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown. MA 02472 USA Telephone: Fax:

617-926-6666 617-926-6262

DEVICE

Trade Name: PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass Ionomer Cement Classification Name: Adhesive, Bracket and Tooth Conditioner, Resin FDA Product Code: DYH, 21 CFR Part 872.3750

PREDICATE DEVICES

Pulpdent Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement GC Fuji Ortho LC (light-cure) GC Fuji Ortho Self-cure Pulpdent Band-Rite

DESCRIPTION AND INTENDED USE

COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT Triple Cure Paste / Paste is substantially equivalent in composition and intended use to the predicate products listed above. Please see Exhibit 4 for the entire comparison.

SAFETY AND EFFECTIVENESS:

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 benefitto-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States. In addition, the predicate products listed above have been given 510 (k) premarket approval as Class II Dental Devices under CFR 872.3750.

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Image /page/1/Picture/11 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2003

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472

Re: K030036

Trade/Device Name: Pulpdent Triple-Cure™ Paste/Paste Resin Reinforced, Glass Ionomer Cement Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH and EMA Dated: December 27, 2002 Received: January 03, 2003

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.

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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), 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) you may obtain. 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,

Susan Roaner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

K030036

510 (k) Number (if known)

Triple-Cure™ Paste/Paste Resin-Reinforced Glass Ionomer Cement Device Name

Indications for Use:

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	or	Over-The-Counter Use
(Per 21 CFR 801.109)

Keim Muly for MSR

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

510(k) Number:	K030036
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Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.