LIME-LITE II

K113711 · Pulpdent Corporation · EJK · Mar 5, 2012 · Dental

Device Facts

• Record ID: K113711
• Device Name: LIME-LITE II
• Applicant: Pulpdent Corporation
• Product Code: EJK · Dental
• Decision Date: Mar 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3250
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Lime-Lite II is a light-cured, radiopaque dental liner/base material; composition includes hydroxyapatite in a urethane dimethacrylate resin. Device is applied by dental professionals to cavity preparations before restoration. Material releases calcium and fluoride ions. Operation involves light-curing to set the material. Benefits include protection of the pulp and support for restorative materials. Used in clinical dental settings.

Clinical Evidence

Bench testing only. Performance metrics: light cure setting time < 20 seconds; working time > 5 minutes; depth of cure 2 mm; compressive strength 238 ± 33 MPa; flexural strength 57 ± 10 MPa; pH 10 ± 0.5; water absorption 0.025 mg/mm³.

Technological Characteristics

Light-cured dental liner/base. Materials: urethane dimethacrylate resin, hydroxyapatite, calcium hydroxide/calcium phosphate tribasic, glass filler. Energy source: external light-curing unit. Form factor: dental restorative material. Shelf-life: two years.

Indications for Use

Indicated for use as a dental liner or base material to line cavity preparations prior to restoration in patients requiring dental restorative procedures.

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 Limelight (K953079)
• Scientific Pharmaceuticals Fluoroseal Dentin Sealer and Cavity Liner (K860633)

Submission Summary (Full Text)

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# PORATION

MAR - 5 2012

80 Oakland Street Watertown, MA 02472 USA

TEL: [phone] FAX: [phone] [e-mail]

#### 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 [e-mail]

#### 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,<br>light cured, radiopaque dental<br>liner/base material in a<br>urethane dimethacrylate base. | Line cavity preparations before<br>restoration. | Acrylate resins |
| | | | Hydroxyapatite |
| | | | Calcium hydroxide and/or<br>Calcium phosphate tribasic |
| | | | Photo-chemistry |
| | | | Glass filler |
| Pulpdent Limelight<br>K953079 | Calcium and fluoride releasing,<br>light cured, radiopaque dental<br>liner/base material in a<br>urethane dimethacrylate base. | Line cavity preparations before<br>restoration. | Acrylate resins |
| | | | Calcium hydroxide |
| | | | Photo-chemistry |
| | | | Glass filler |
| Scientific Pharmaceuticals<br>Fluoroseal<br>K860633 | Calcium and fluoride releasing,<br>light cured, radiopaque dental<br>liner/base material in a resin<br>base. | Line cavity preparations before<br>restoration | Resin Base |
| | | | Hydroxyapatite |
| | | | Photo-chemistry |

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# PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

TEL: [phone] FAX: [phone] [e-mail]

#### 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 [phone] or [phone] 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:

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.

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

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