Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin. Lime-Life II is used to line cavity preparations before restoration.

Device Description

Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Lime-Lite II device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Bench Test)	Reported Device Performance
Light Cure Setting Time: < 20 seconds	Light Cure Setting Time: < 20 seconds
Working time in ambient light: > 5 minutes	Working time in ambient light: > 5 minutes
Depth of cure: 2 mm	Depth of cure: 2 mm
Compressive Strength: Not explicitly stated as acceptance criteria, but compared to predicates.	Compressive Strength: 238 ± 33 MPa, 34,500 ± 4785 p.s.i.
Flexural Strength: Not explicitly stated as acceptance criteria, but compared to predicates.	Flexural Strength: 57 ± 10 MPa, 8265 ± 1450 p.s.i.
Density: Not explicitly stated as acceptance criteria, but compared to predicates.	Density: 1.620 g/ml
pH: Not explicitly stated as acceptance criteria, but compared to predicates.	pH: 10 ± 0.5
Water absorption: Not explicitly stated as acceptance criteria, but compared to predicates.	Water absorption: 0.025 mg/mm³ / 25µg/ mm³
Shelf-life: Not explicitly stated as acceptance criteria, but compared to predicates.	Shelf-life: Two years

2. Sample size used for the test set and the data provenance:

The document primarily describes bench testing.
The exact sample sizes for each specific physical/chemical test (e.g., number of specimens for compressive strength) are not provided.
Data provenance (country of origin, retrospective/prospective) is not applicable as this is bench testing, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission relies on bench testing, not expert-adjudicated clinical data to establish ground truth. The "truth" in this context is the measured physical/chemical properties of the material against established standards for dental materials.

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

Not applicable. No human adjudication of clinical findings 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:

No. An MRMC comparative effectiveness study was not conducted. This device is a dental material, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a material, not an algorithm.

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

The "ground truth" for the bench tests is the objective measurement of the physical and chemical properties of the Lime-Lite II material, compared against the expected performance characteristics of a calcium hydroxide cavity liner and the properties of the predicate devices. These properties are established through standardized laboratory testing methods.

8. The sample size for the training set:

Not applicable. This product is a dental material, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described.

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

Not applicable. (See point 8).

Summary of the Study Proving Device Meets Acceptance Criteria:

The provided document describes a bench testing summary for Lime-Lite ™ II to demonstrate its safety and effectiveness. The study's objective was to show that Lime-Lite ™ II performs as intended and is substantially equivalent to its predicate devices (Pulpdent Limelight and Scientific Pharmaceuticals Fluoroseal).

The study involved a series of standard laboratory tests to measure various physical and chemical properties of the Lime-Lite™ II material. These tests included:

Light Cure Setting Time
Working time in ambient light
Depth of cure
Compressive Strength
Flexural Strength
Density
pH
Water absorption
Shelf-life

The acceptance criteria for several of these properties (Light Cure Setting Time, Working time, Depth of cure) appear to be defined performance thresholds (e.g., < 20 seconds, > 5 minutes, 2 mm). For other properties like strength, density, pH, and water absorption, the document presents the measured values, implying that these values were found to be acceptable and comparable to the predicate devices, though explicit numerical acceptance criteria for each were not individually listed. The document states that the test results "demonstrate that Lime-Lite II performs as intended" and concludes that it is "substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed." This conclusion is reinforced by "organizational experience with Lime-Lite" and the successful, long-term use of predicate devices without adverse events.

Summary

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PORATION

MAR - 5 2012

80 Oakland Street Watertown, MA 02472 USA

TEL: 617-926-6666 FAX: 617-926-6262 Pulpdent@pulpdent.com

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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

Telephone: Fax: Email.

617-926-6666 617-926-6262 ken@pulpdent.com

DEVICE:

Trade Name: Lime-Lite II Classification Name: Calcium hydroxide cavity liner. FDA Product Code: 76 EJK, 21 CFR Part 872.3250

PREDICATE DEVICES:

Pulpdent Limelight Scientific Pharmaceuticals Fluoroseal Dentin Sealer and Cavity Liner

DESCRIPTION AND INTENDED USE:

Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin. Lime-Lite II is used to line cavity preparations before restoration.

COMPARISON WITH PREDICATE PRODUCTS:

Lime-Lite II is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.

PRODUCT	DESCRIPTION	INTENDED USE	COMPOSITION
Lime-Lite II	Calcium and fluoride releasing,light cured, radiopaque dentalliner/base material in aurethane dimethacrylate base.	Line cavity preparations beforerestoration.	Acrylate resins
			Hydroxyapatite
			Calcium hydroxide and/orCalcium phosphate tribasic
			Photo-chemistry
			Glass filler
Pulpdent LimelightK953079	Calcium and fluoride releasing,light cured, radiopaque dentalliner/base material in aurethane dimethacrylate base.	Line cavity preparations beforerestoration.	Acrylate resins
			Calcium hydroxide
			Photo-chemistry
			Glass filler
Scientific PharmaceuticalsFluorosealK860633	Calcium and fluoride releasing,light cured, radiopaque dentalliner/base material in a resinbase.	Line cavity preparations beforerestoration	Resin Base
			Hydroxyapatite
			Photo-chemistry

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

TEL: 617-926-6666 FAX: 617-926-6262 Pulpdent@pulpdent.com

Summary of Performance Testing - Bench

The following test results demonstrate that Lime-Lite II performs as intended:

Light Cure Setting Time	< 20 seconds
Working time in ambient light	> 5 minutes
Depth of cure	2 mm
Compressive Strength	238 ± 33 MPa, 34,500 ± 4785 p.s.i.
Flexural Strength	57 ± 10 MPa, 8265 ± 1450 p.s.i.
Density	1.620 g/ml
pH	10 ± 0.5
Water absorption	0.025 mg/mm³/ 25µg/ mm³
Shelf-life	Two years

SAFETY AND EFFECTIVENESS:

From the above comparisons, the bench testing and the organizational experience with Lime-Lite, it can be concluded that Lime-Lite II is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.

The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3250 and CFR 872.3260 and have been used successfully by dental professionals for more than ten years with no reports of adverse events.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

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

MAR - 5 2012

Re: K113711

Trade/Device Name: Lime-Lite™ II Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Codes: EJK Dated: December 13, 2011 Received: December 21, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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

510(k) Number (if known): K 113711

Device Name: Pulpdent Lime-Lite™ II

Indications For Use:

Prescription Use X . (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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Roys

(Division Sign-Off) 'vision of Anesthesiology, General Hospital iection Control, Dental Devices

Page 1 of 1

510(k) Number:

1-10

Regulation Number and Section

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.