PULPDENT Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the advantages of glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ is a fluoride releasing, light-cure, self-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching gel to adhere orthodontic brackets to tooth surfaces

Device Description

PULPDENT Triple-Cure™ Reinforced Glass lonomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the of thouonic cement that ban be dood as a bracked as a brache of early of the edire" ("" (" is a fluoride releasing, light-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching gel to adhere orthodontic brackets to tooth surfaces.

AI/ML Overview

The provided Premarket Notification (510(k)) for the PULPDENT Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement does not contain a study that establishes specific acceptance criteria and then proves the device meets those criteria through empirical testing.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices, as well as referencing general information about the safety and effectiveness of similar materials.

Here's a breakdown based on the information provided and what is explicitly missing in relation to your request about acceptance criteria and a study proving their fulfillment:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: No specific numerical or qualitative acceptance criteria (e.g., minimum bond strength, maximum debonding rate, fluoride release levels, etc.) are stated in the document.
Reported Device Performance: No specific performance data for the Pulpdent Triple-Cure™ device is reported. The document states it "combines the advantages of glass ionomer cement with the added strength of dental resin technology" but provides no quantitative evidence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No test set or associated study data proving performance are presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment related to specific performance testing is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication process is described.

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 type of study (MRMC, AI assistance) is completely irrelevant to a dental cement device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This question pertains to AI/algorithm performance and is not relevant to this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth for device performance is established or used in a study described here. The "ground truth" for the submission's argument is the established safety and effectiveness of the predicate devices and the general usage of similar materials over time.

8. The sample size for the training set

Not applicable. This question relates to machine learning models and is not relevant to this dental cement.

9. How the ground truth for the training set was established

Not applicable. This question relates to machine learning models and is not relevant to this dental cement.

Summary of the FDA's decision based on the provided text:

The FDA granted 510(k) clearance based on substantial equivalence to predicate devices (GC Fuji Ortho LC, GC Fuji Ortho Self-cure, Pulpdent Band-Rite). The argument for safety and effectiveness is largely based on:

The device being "substantially equivalent in composition and intended use" to already approved predicate devices.
Broad statements about the "high benefit-to-risk ratio" and "trouble-free" nature of similar materials (composites and glass ionomers) over "about 20 years," citing an NIH Technology Assessment Conference.
The fact that predicate products have already received 510(k) premarket approval.

In essence, this submission does not contain empirical performance data generated from a specific study with defined acceptance criteria for the Pulpdent Triple-Cure™ device itself. It relies on the regulatory pathway of substantial equivalence, asserting that because it is similar enough to already-approved and widely-used devices, it is safe and effective without needing new, independent performance studies beyond what's stated.

Summary

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PULPDENT CORPORATION

K014138

510 k Premarket Notification

Pulpdent Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement

MAR 1 4 2002

EXHIBIT 2

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

PREDICATE DEVICES

GC Fuji Ortho LC (light-cure) GC Fuii Ortho Self-cure Pulpdent Band-Rite

DESCRIPTION AND INTENDED USE

COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT Triple Cure Orthodontic Bracket Adhesive 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, 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: K014138

Trade/Device Name: Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Regulation Number: 872.3750 Regulation Name: Adhesive, Bracket and Tooth Conditioner, Resin Regulatory Class: II Product Code: DYH Dated: December 13, 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 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.

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.

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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 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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INDICATIONS FOR USE STATEMENT

K014138

510 (k) Number (if known)

Device Name: PULPDENT Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement

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)

Over-The-Counter Use

(Division Sign-Off) Chelsion of Dental, Infection Control, and General Hospital Devices 610(k) Number ----------------------------------------------------------------------------------------------------------------------------------------------------------------

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.