NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste that has a pH > 12, is easily removed from the root canal with water, has been designed for ease of handling and will flow through a 27 gauge applicator tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device called NuCal. This submission focuses on establishing substantial equivalence to predicate devices based on design, composition, performance, and intended use, rather than presenting a study of a novel AI/ML device. Therefore, much of the requested information about AI model performance is not applicable.

Here's an analysis of the available information:

Acceptance Criteria and Reported Device Performance for NuCal

The acceptance criteria are established through bench testing to demonstrate that NuCal performs as intended and is substantially equivalent to predicate devices.

Acceptance Criteria	Reported Device Performance
Appearance	Thin white paste.
Consistency	Smooth, homogenous, thin paste.
Paste characteristic	Dispenses easily through 27 gauge applicator tip without clogging or force.
Specific gravity	1.470 g/ml
pH	> 12
Radiopacity	Equal to the same thickness of aluminum.
Shelf life	Two years, based on accelerated testing at 37°C.

Regarding the other requested information, it is not applicable or not provided in the document for the following reasons:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not relevant as no AI/ML model was being tested. The "test set" here refers to the samples of NuCal undergoing bench testing. The document does not specify the number of samples used for each bench test, nor their provenance beyond being manufactured by Pulpdent Corporation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product's bench tests is typically established through standardized laboratory procedures and measurements, not expert consensus in the way it's used for AI diagnostic tasks.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI models, not for bench testing of a physical substance.
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 document is for a dental material (calcium hydroxide paste), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. NuCal is a physical product, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance characteristics in the table, the ground truth is based on physical and chemical measurements performed in a laboratory setting (e.g., pH meter for pH, specific gravity meter, visual inspection for appearance/consistency, radiographic assessment for radiopacity, accelerated aging for shelf life).
The sample size for the training set: Not applicable. There is no AI model or "training set" in this context.
How the ground truth for the training set was established: Not applicable, as there is no AI model or training set.

In summary: The provided document is a 510(k) summary for a conventional medical device (a dental material), not an AI/ML powered device. The "study" described is a series of bench tests to demonstrate the physical and chemical properties of the NuCal product, and its substantial equivalence to previously cleared predicate devices.

Summary

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

41200003

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

APR - 5 2012

510(k) SUMMARY

December 28, 2011

Contact:

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: Fax: Email:

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

DEVICE:

Trade Name: NuCal Classification Name: Calcium hydroxide cavity liner. FDA Product Code: 76 EJK, 21 CFR Part 872.3250

PREDICATE DEVICES:

Pulpdent TempCanal Pulpdent Multi-Cal UltraDent UltraCal XS

INTENDED USE: NuCal is used by the dental professional as a cavity liner and as a temporary root canal dressing.

DESCRIPTION: NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste that has a pH > 12, is easily removed from the root canal with water, has been designed for ease of handling and will flow through a 27 gauge applicator tip.

COMPARISON WITH PREDICATE PRODUCTS:

NuCal is substantially equivalent in design, composition, performance and intended use to the predicate products:

PRODUCT	DESCRIPTION	INTENDED USE	COMPOSITION
NuCal	Non-setting, pre-mixed,radiopaque calcium hydroxidepaste	Cavity liner and temporary rootcanal dressing.	Calcium hydroxideBarium sulfatePolyethylene glycolWater
Pulpdent TempCanalK944945	Non-setting, pre-mixed,radiopaque calcium hydroxidepaste	Cavity liner and temporary rootcanal dressing.	Calcium hydroxideBarium sulfateAqueous gel matrix
Pulpdent Multi-CalK944945	Non-setting, pre-mixed,radiopaque calcium hydroxidepaste	Cavity liner and temporary rootcanal dressing.	Calcium hydroxideBarium sulfateAqueous gel matrix
UltraDent UltraCal XSK970114	Non-setting, pre-mixed,radiopaque calcium hydroxidepaste	Cavity liner and temporary rootcanal dressing.	Calcium hydroxideBarium sulfateAqueous matrix

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

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

SUMMARY OF PERFORMANCE TESTING - BENCH

The following test results demonstrate that NuCal performs as intended:

Appearance	Thin white paste.
Consistency	Smooth, homogenous, thin paste.
Paste characteristic	Dispenses easily through 27 gauge applicator tip without clogging or force
Specific gravity	1.470 g/ml
pH	> 12
Radiopacity	Equal to the same thickness of aluminum
Shelf life	Two years, based on accelerated testing at 37°C

CONCLUSION:

From the above comparisons, the bench testing and the decades of organizational experience with calcium hydroxide preparations, it can be concluded that NoCal is substantially equivalent in design, composition, performance and intended use 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 have been used by dental professionals for more than 20 years. A search of the relevant scientific literature shows that calcium hydroxide pastes used for cavity lining and root canal dressing have been studied since the 1950's. See References below.

REFERENCES

American Dental Association. Accepted Dental Therapeutics, 39th edition. Calcium 1. hydroxide preparations. 1982 July; 300-301.
1. Behnen MJ, West LA, Liewehr FR, et al. Antimicrobial activity of several calcium hydroxide preparations in root canal dentin. J Endod 2001 Dec; 27(12):765-7.
ന് Berk H. The effect of calcium hydroxide-methyl cellulose paste on the dental pulp. J Dent Children. 17(4) Oct. 1950.
Berk H. Maintaining vitality of injured permanent anterior teeth. JADA 1954; 49:391-401 4.
Berk H. Preservation of the dental pulp in deep seated cavities. J Amer Dent Assoc 1957; 5. 54:226-33.
Berk H, Krakow AA. Efficient Vital Pulp Therapy. Dent Clin NA. 1965 July; 373-85. 6.
Berk H, Stanley HR. Pulp healing following capping in human sound and carious teeth. J 7. Dent Res. 1958; 37(66) Abstract.

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80 Oakland Street Watertown, MA 02472 USA

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

ಹ Heithersay GS. Calcium hydroxide in the treatment of pulpless teeth with associated pathology. J Brit Endod Society, 1975;8(2), 74-93.
1. Kirk EEJ, Lim KC, Khan MOG. A comparison of dentinogenesis on pulp capping with calcium hydroxide in paste and cement form. Oral Surg Oral Med Oral Pathol 1989; 68(2):210-19.
Kundsin RB, Perkins RE. Test of antibacterial activity of Pulpdent TempCanal (Calcium 10. hydroxide preparation). Kundsin Laboratory, Harvard Medical School, Brigham and Women's Hospital.
1. Phaneuf RA, Frankl SN, Ruben MP. A comparative histological evaluation of three calcium hydroxide preparations on the human primary dental pulp. J Dent for Children. 1968 January; 35:61-76.
Subay RK, Suzuki S, et al. Human pulp response after partial pulpotomy with two calcium 12. hydroxide products. Oral Surg Oral Med Oral Pathol Oral Radiol Endo 1995; 80(3):330-7.

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Public Health Service

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

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

APR - 5 2012

Re: K120003 Trade/Device Name: Nucal Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: February 17, 2012 Received: February 21, 2012

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/CDRHOffice s/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Wh 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

Enclosure

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Indications for Use

510(k) Number: K120003

Device Name: Pulpdent NuCal

Indications For Use:

NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste used as a cavity liner and as a temporary root canal dressing.

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 Renner

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

510(k) Number: K120003

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.