Pulpdent No-Mix Orthodontic Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

Device Description

PULPDENT No-Mix Orthodontic Bracket Adhesive is a fluoride-releasing, self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a dental adhesive. It focuses on establishing substantial equivalence to existing predicate devices rather than directly presenting acceptance criteria and detailed study performance data for a new, innovative device that would typically involve such a study.

Therefore, many of the requested categories for information about acceptance criteria, study details, and ground truth establishment are not directly available or applicable in this document. The submission's core argument is that the "Pulpdent No-Mix Orthodontic Bracket Adhesive" is "substantially equivalent" to already approved devices, implying it meets the same safety and effectiveness standards without requiring new, specific performance studies outlined here.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Safety and Effectiveness	The device must demonstrate safety and effectiveness for its intended use, especially given the "high benefit-to-risk ratio" of similar materials over 20 years, with "no evidence of short-term or long-term risk" and "no suspicion of any problems after virtually billions of procedures." It must also align with the safety and effectiveness profile of predicate devices.	The document states that "PULPDENT No Mix Orthodontic Adhesive is substantially equivalent in composition and intended use to the predicate product listed above." This implies that it meets similar safety and effectiveness standards, as the FDA later concludes that the device is "substantially equivalent" to legally marketed predicate devices, hence permitting its market entry.
Substantial Equivalence	The device must be "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" (as per the FDA's letter). This implies that its technological characteristics and performance are comparable to the predicate devices.	The FDA concluded that the device is "substantially equivalent" to the predicate devices. The submission itself states, "PULPDENT No Mix Orthodontic Adhesive is substantially equivalent in composition and intended use to the predicate product listed above." (Predicate devices listed are GAC OrthoLoc, GAC One-Step, Reliance Rely-a-Bond No Mix Orthodontic Adhesive, and Reliance Rely-a-Bond w/Fluoride No Mix Adhesive). This equivalence is the primary "performance" demonstrated for this 510(k) submission.
Composition and Intended Use	The device's composition and intended use should be comparable to predicate devices.	"PULPDENT No Mix Orthodontic Adhesive is substantially equivalent in composition and intended use to the predicate product listed above." The intended use is clearly defined as "a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces." Composition is generally described as a "fluoride-releasing, self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel." Specific compositional details for comparison are not provided in this excerpt but would have been in Exhibit 4 (not included).

Since this is a 510(k) submission based on "substantial equivalence" to predicate devices, a detailed standalone study with specific acceptance criteria and performance metrics for this new device is not typically required in the same way as for novel devices. Instead, the argument relies heavily on the established safety and effectiveness of the predicate devices.

Given the nature of the provided document, the following points cannot be extracted directly from the text:

2. Sample size used for the test set and the data provenance: Not mentioned. The reliance is on the general history and performance of similar materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/mentioned. Ground truth is not established in the context of new data generation for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/mentioned.
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: Not applicable. This is a dental adhesive, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental adhesive.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for this device. The submission relies on the established safety and long-term history of similar dental materials, citing "general usage...over about 20 years" and "virtually billions of procedures in the United States" for composites and glass ionomers. implicitly, the "ground truth" for these materials is their proven track record of safety and efficacy.
8. The sample size for the training set: Not applicable/mentioned. This document does not describe a machine learning model.
9. How the ground truth for the training set was established: Not applicable/mentioned. This document does not describe a machine learning model.

Summary

{0}------------------------------------------------

2,2

510 k Premarket Notification

Pulpdent No-Mix Orthodontic Bracket Adhesive

EXHIBIT 2

MAR 1 4 2002

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

RESPONSE TO SMDA OF 1990

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 No-Mix Orthodontic Bracket Adhesive Classification Name: Adhesive, Bracket and Tooth Conditioner, Resin FDA Product Code: DYH. Part 872.3750

PREDICATE DEVICES:

GAC OrthoLoc GAC One-Step Reliance Rely-a-Bond No Mix Orthodontic Adhesive Reliance Rely-a-Bond w/Fluoride No Mix Adhesive

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT No Mix Orthodontic Adhesive is substantially equivalent in composition and intended use to the predicate product 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 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. In addition, the predicate products listed above have been given 510 (k) premarket approval as Class II Dental Devices under CFR 872.3750.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure or bird-like shape, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2002

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

Re: K014133

Trade/Device Name: Pulpdent No-Mix Orthodontic Bracket Adhesive Regulation Number: 872.3750 Regulation Name: Adhesive, Bracket and Tooth Conditioner, Resin Regulatory Class: II Product Code: DYH Dated: December 11, 2001 Received: December 17, 2001

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 (2012) 1) 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.

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.

{2}------------------------------------------------

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 vours

Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

KO14133

510 (k) Number (if known)

PULPDENT NO MIX ORTHODONTIC BRACKET ADHESIVE 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
(Per 21 CFR 801.109)	or	Over-The-Counter Use
	(Division Sign-Off)
	Division of Dental, Infection Control,
	and General Hospital Devices
	K014133

F 1 (k) Number _

I UI TIL

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.