NUCAL

K120003 · Pulpdent Corporation · EJK · Apr 5, 2012 · Dental

Device Facts

• Record ID: K120003
• Device Name: NUCAL
• Applicant: Pulpdent Corporation
• Product Code: EJK · Dental
• Decision Date: Apr 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste; pH > 12. Device dispensed via 27-gauge applicator tip into dental cavities or root canals. Used by dental professionals in clinical settings. Paste consistency allows for easy placement and removal with water. Acts as a liner or temporary dressing to support dental procedures. Benefits include ease of handling and radiopacity for visualization.

Clinical Evidence

Bench testing only. Performance metrics include: appearance (thin white paste), consistency (smooth, homogenous), flow through 27-gauge tip, specific gravity (1.470 g/ml), pH (> 12), and radiopacity (equal to aluminum). Shelf life validated via accelerated testing at 37°C. No clinical trials were conducted; equivalence is supported by bench data and historical literature on calcium hydroxide preparations.

Technological Characteristics

Non-setting, pre-mixed, radiopaque paste. Composition: Calcium hydroxide, Barium sulfate, Polyethylene glycol, Water. pH > 12. Radiopacity equal to aluminum. Dispensed via 27-gauge applicator tip. Mechanical/chemical device; no software or energy source.

Indications for Use

Indicated for use by dental professionals as a cavity liner and temporary root canal dressing.

Regulatory Classification

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.

Predicate Devices

• Pulpdent TempCanal (K944945)
• Pulpdent Multi-Cal (K944945)
• UltraDent UltraCal XS (K970114)

Submission Summary (Full Text)

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# PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

41200003

Tel: [phone] Fax: [phone] Email: [e-mail]

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 [e-mail]

#### 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,<br>radiopaque calcium hydroxide<br>paste | Cavity liner and temporary root<br>canal dressing. | Calcium hydroxide<br>Barium sulfate<br>Polyethylene glycol<br>Water |
| Pulpdent TempCanal<br>K944945 | Non-setting, pre-mixed,<br>radiopaque calcium hydroxide<br>paste | Cavity liner and temporary root<br>canal dressing. | Calcium hydroxide<br>Barium sulfate<br>Aqueous gel matrix |
| Pulpdent Multi-Cal<br>K944945 | Non-setting, pre-mixed,<br>radiopaque calcium hydroxide<br>paste | Cavity liner and temporary root<br>canal dressing. | Calcium hydroxide<br>Barium sulfate<br>Aqueous gel matrix |
| UltraDent UltraCal XS<br>K970114 | Non-setting, pre-mixed,<br>radiopaque calcium hydroxide<br>paste | Cavity liner and temporary root<br>canal dressing. | Calcium hydroxide<br>Barium sulfate<br>Aqueous matrix |

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# PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

Tel: [phone] Fax: [phone] Email: [e-mail]

### 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.
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- ಹ Heithersay GS. Calcium hydroxide in the treatment of pulpless teeth with associated pathology. J Brit Endod Society, 1975;8(2), 74-93.
- 9. 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.
- 11. 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 [phone] or [phone] 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