PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.

Device Description

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a dental device called "Pulpdent Putty Dam." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way a clinical trial for an AI/ML medical device would.

Therefore, many of the requested categories are not applicable to this document. I will fill in the available information and explain why other sections are not present.

Acceptance Criteria and Device Performance Study for Pulpdent Putty Dam

This 510(k) Premarket Notification for Pulpdent Putty Dam primarily establishes substantial equivalence to predicate devices, rather than presenting a performance study against specific, quantified acceptance criteria. The claim of safety and effectiveness rests on the general usage history of similar materials and regulatory approvals of predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Safety	No short-term or long-term risks	"General usage of these materials over about 10 years indicates a high benefit-to-risk ratio. There is no evidence of short-term or long-term risk or suspicion of any problems."
Effectiveness/Intended Use	Protection of soft tissue by creating a physical barrier during bleaching, air abrasion, and etching procedures.	"PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier." (Based on comparison to predicate devices with over 10 years of general usage demonstrating safety and effectiveness.)
Substantial Equivalence	Equivalent in composition and intended use to predicate devices	"PULPDENT PUTTY DAM is substantially equivalent in composition and intended use to the products listed above."

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission does not describe a test set or a study with a specific sample size. The safety and effectiveness claims are based on:

General usage history of similar materials (predicate devices) over approximately 10 years.
The fact that predicate products have received 510(k) Premarket approval.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. There was no specific test set requiring ground truth established by experts. The document mentions "The safety and effectiveness of these resins is supported by the editors of Reality. 2002." While "Reality" is a dental product review publication, this is not a formal ground truth establishment process for a specific test set.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring adjudication was described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance. The Pulpdent Putty Dam is a physical barrier material, not an interpretative diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical dental material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth," in the context of this 510(k), is implicitly based on the established safety record and performance of the predicate devices in clinical use over time. It relies on:

Expert Consensus/Clinical Experience: "General usage of these materials over about 10 years indicates a high benefit-to-risk ratio."
Regulatory Precedent: The predicate devices having received 510(k) approvals and being classified as Class I Dental Devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is not an AI/ML algorithm requiring ground truth establishment for a training set.

Summary

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SEP 2 6 2002

510 k Premarket Notification Pulpdent PUTTY DAM

EXHIBIT 2

KQ2522

SUMMARY OF SAFETY AND EFFECTIVENESS DAT

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA

Telephone: 617-926-6666 Fax: 617-926-6262 Email: Pulpdent@pulpdent.com

DEVICE NAME: PULPDENT PUTTY DAM

PREDICATE DEVICES:

ULTRA DENT OPAL DAM DEN-MAT PAINT ON RUBBER DAM PREMIER PERFECTA BLOCK OUT RESIN SHOFU NIVEOUS LIQUID DAM LUMA LITE LUMA BLOCK INTERDENT FAST DAM BriteSmile BARRIER MATERIAL

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT PUTTY DAM is substantially equivalent in composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.

SAFETY AND EFFECTIVENESS:

General usage of these materials over about 10 years indicates a high benefit-to-risk ratio. There is no evidence of short-term or long-term risk or suspicion of any problems. The safety and effectiveness of these resins is supported by the editors of Reality. 2002. In addition, the predicate products listed above have been given 510 (k) Premarket approval as Class I Dental Devices under CFR 872.4565 and 872.6300. Please see Exhibit 4 for 510(k) numbers.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 26 2002

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street P.O. Box 780 Watertown, Massachusetts 02472

Re: K022522

Trade/Device Name: Pulpdent Putty Dam Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EIE Dated: July 25, 2002 Received: July 30, 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.

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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 accurics. 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

Timothy A Ulatowski 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

K022522

510 (k) Number (if known)

PULPDENT PUTTY DAM 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)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,Infection Control, Dental Devices

510(k) Number:
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Regulation Number and Section

§ 872.6300 Rubber dam and accessories.

(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.