ORALUBE

• K Number: K090457
• Device Name: ORALUBE
• Manufacturer: PULPDENT CORPORATION
• Date Cleared: 2009-05-21 ( 87 days)
• Product Code: ONK
• Regulation Number: 880.6375
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

OraLube is a water-soluble, viscous liquid coating intended to be used an intraoral and perioral release agent for the following clinical situations:

• Taking an impression, in which OraLube is placed on the gums and inside the lip (areas not critical to the final outcome of the prosthesis) to facilitate the release of impression material and is applied to the lips and the skin around the mouth to prevent adherence of impression material;
• Using a dental cement or adhesive, in which OraLube is applied to adjacent hard and soft tissue and to the lips and skin around the mouth to prevent adherence of the cement or adhesive;
• Placement of a rubber dam, in which OraLube is brushed on the tooth to facilitate slipping the rubber dam over it.
• Long procedures, in which OraLube can be used to protect the lips from drying out and cracking.

Device Description

Pulpdent OraLube is a water-soluble, viscous liquid coating intended to be used as an intraoral and perioral release agent, slip agent, lubricant, lip and skin protector.

AI/ML Overview

The provided text describes a 510(k) summary for a dental device called "Pulpdent OraLube." The 510(k) process is for demonstrating substantial equivalence to a predicate device, rather than performing a de novo study with acceptance criteria and performance metrics.

Therefore, the input text does not contain the specific information required to answer the questions regarding acceptance criteria, device performance, study details, or ground truth establishment. It primarily focuses on comparing the new device to a predicate device ("Pulpdent Separating Medium K 896653") to establish "substantial equivalence" in performance, intended use, safety, and effectiveness.

Here's a breakdown of why this information is missing based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission relies on "substantial equivalence" to a predicate device that has been "on the market and used successfully by dental professionals for many years with no serious safety or effectiveness problems." This implies an existing track record for the predicate, not new performance data for OraLube against specific criteria.

2. Sample sizes used for the test set and the data provenance: Not applicable or provided. No specific test set or study data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. No ground truth establishment activity is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or provided.

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 device is a water-soluble lubricant; it is not an AI-assisted diagnostic tool or an imaging device, so MRMC studies are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual application product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or provided.

8. The sample size for the training set: Not applicable or provided. No training set is mentioned as this device is not an AI/ML product.

9. How the ground truth for the training set was established: Not applicable or provided.

In summary, the provided document is a 510(k) summary for a Class I medical device, which typically relies on demonstrating equivalence to existing legally marketed devices rather than presenting extensive new performance study data against pre-defined acceptance criteria. Therefore, the information requested in your prompt related to clinical trials, expert review, training sets, and ground truth is not found in this type of submission.

Summary

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EXHIBIT 2

MAY 21 2009 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: [phone] Fax: [phone] [e-mail]

DEVICE:

Trade Name: Pulpdent OraLube Classification Name: Class: FDA Product Code:

PREDICATE DEVICE:

Pulpdent Separating Medium K 896653

DESCRIPTION AND INTENDED USE:

Pulpdent OraLube is a water-soluble, viscous liquid coating intended to be used as an intraoral and perioral release agent, slip agent, lubricant, lip and skin protector in the following clinical situations:

• Taking an impression, in which OraLube is placed on the gums and inside the lip (areas not critical to the final outcome of the prosthesis) to facilitate the release of impression material and is applied to the lips and the skin around the mouth to prevent adherence of impression material;
• · Using a dental cement or adhesive, in which OraLube is applied to adjacent hard and soft tissue and to the lips and skin around the mouth to prevent adherence of the cement or adhesive;
• · Placement of a rubber dam, in which OraLube is brushed on the tooth to facilitate slipping the rubber dam over it.
• · Long procedures, in which OraLube can be used to protect the lips from drying out and cracking.

COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent OraLube is substantially equivalent in performance, intended use, safety and effectiveness to the predicate product listed above. The predicate product has been found substantially equivalent under the 510(k) Premarket Notification process under CFR 872.3690.

SAFETY AND EFFECTIVENESS:

Pulpdent OraLube is substantially equivalent in performance, intended use, safety and effectiveness to the predicate product listed above that has been on the market and used successfully by dental professionals for many years with no serious safety or effectiveness problems. Pulpdent OraLube is fabricated from materials that are often used in food.

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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 features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY 21 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090457

Trade/Device Name: Pulpdent OraLube Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: ONK Dated: February 18, 2009 Received: February 24, 2009

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 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Punner

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

K 090457

Device Name:

Pulpdent OraLube

Indications For Use:

OraLube is a water-soluble, viscous liquid coating intended to be used an intraoral and perioral release
agent for the following clinical situations: agent for the following clinical situations:

• • Taking an impression, in which OraLube is placed on the gums and inside the lip (areas not
    critical to the the prosthesis) to facilitate the release of invest and of the ministedon, in which cracule is placed on the gums and inside the lip (areas not
    critical to the final outcome of the prosthesis) to facilitate the release of imp and the more of the prosifiesis) to the prosilies the release of impression material and
• Using a dental cement, in which OraLube is applied to the lips and skin around the mouth and to � adjacent hard and soft the which Oracube is applied to the lips and
• Placement of a rubber dam, in which OraLube is brushed on the tooth to be treated to facilitate
  slipping the rubber dam over it. �
• Long procedures, in which OraLube can be used to protect the lips from drying out and cracking, �

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF IEEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Keri Molter for ALSR

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

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510(k) Number:

Regulation Number and Section

§ 880.6375 Patient lubricant.

(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.