EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL

K113818 · Pulpdent Corporation · EBC · Mar 21, 2012 · Dental

Device Facts

• Record ID: K113818
• Device Name: EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
• Applicant: Pulpdent Corporation
• Product Code: EBC · Dental
• Decision Date: Mar 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2

Intended Use

Embrace Pit and Fissure Sealant, Low Fill is used by dental professionals to seal the pits and fissures in teeth.

Device Story

Embrace WetBond Pit and Fissure Sealant, Low Fill is a fluoride-releasing, light-cured, Bisphenol A-free acrylate resin dental material. It is applied by dental professionals to the pits and fissures of teeth to provide a physical barrier. The material is light-cured using a dental curing light to initiate polymerization, resulting in a hardened sealant. The device is used in a clinical dental setting. By sealing pits and fissures, the device acts as a preventive measure against dental caries. The low-fill formulation (<10% filled) is available in tooth-colored and off-white shades.

Clinical Evidence

Bench testing only. Performance metrics: density 1.160 g/mL, working time >5 minutes, light cure time 20 seconds, depth of cure 1.88 mm, film thickness 9 µm, compressive strength 228 ± 21 MPa, diametral tensile strength 37 ± 2 MPa.

Technological Characteristics

Fluoride-releasing, light-cured acrylate resin; <10% filled; available in tooth-colored and off-white shades. Polymerization via photo-chemistry (light-cured).

Indications for Use

Indicated for use by dental professionals to seal pits and fissures in teeth. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Predicate Devices

• Pulpdent Embrace™ WetBond™ Pit and Fissure Sealant (K020287)
• Pulpdent Embrace™ Clear Sealant (K052281)

Submission Summary (Full Text)

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# 113818 PULPDENT CORPORATION

MAR 2 1 2012

80 Oakland Street Watertown. MA 02472 USA

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

## 510(k) Summary

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown. MA 02472 USA

617-926-6666 Telephone: Fax: [phone] [e-mail]

### DEVICE:

Trade Name: Embrace™ WetBond™ Pit and Fissure Sealant, Low Fill Classification Name: Pit and Fissure Sealant and Conditioner FDA Product Code: 76 EBC, 21 CFR Part 872.3765

### PREDICATE DEVICES:

Pulpdent Embrace™ WetBond™ Pit and Fissure Sealant Pulpdent Embrace™ Clear Sealant

## DESCRIPTION:

Embrace Pit and Fissure Sealant, Low Fill is a fluoride releasing, light-cured acrylate resin, with no Bisphenol A, that is less than 10% filled and is available in two shades, tooth-colored and off-white.

#### INTENDED USE:

Embrace Pit and Fissure Sealant, Low Fill is used by dental professionals to seal the pits and fissures in teeth.

## COMPARISON WITH PREDICATE PRODUCTS:

Embrace Pit and Fissure Sealant, Low Fill is substantially equivalent in design, composition, performance and intended use to the predicate products. The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3765.

A summary of the comparison:

| PRODUCT | DESCRIPTION | INTENDED USE | COMPOSITION |
|------------------------------------------------------|------------------------------------------------------------------|-------------------------------------|----------------------------------------------------|
| <b>Embrace Pit and Fissure<br/>Sealant, Low Fill</b> | Fluoride releasing, light cured,<br>acrylate resins | Seal the pits and fissures in teeth | Acrylate resins<br>Photo-chemistry |
| Embrace Pit and Fissure<br>Sealant<br>K020287 | Fluoride releasing, light cured,<br>glass-filled acrylate resins | Seal the pits and fissures in teeth | Acrylate resins<br>Photo-chemistry<br>Glass filler |
| Embrace Clear Sealant<br>K052281 | Fluoride releasing, light cured,<br>acrylate resins | Seal the pits and fissures in teeth | Acrylate resins<br>Photo-chemistry |

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## PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA .

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

## 510(k) Summary

## SUMMARY OF PERFORMANCE TESTING - Bench

The following test results demonstrate that Embrace Pit and Fissure Sealant, Low Fill performs as intended:

| Density / Specific gravity | 1.160 g / mL |
|------------------------------------------|-------------------------------------|
| Working time in ambient light | > 5 minutes |
| Light cure setting time | 20 seconds |
| Depth of cure after 20 second light cure | 1.88 mm |
| Film thickness | 9 µm |
| Compressive Strength | 33,120 ± 3000 p.s.i. / 228 ± 21 MPa |
| Diametral Tensile Strength | 5,365 ± 300 p.s.i. / 37 ± 2 MPa |
| Film Thickness | 9 µm |

## CONCLUSION:

From the above comparisons, the bench testing, a search of the relevant scientific literature and the organizational experience with Embrace resins, it can be concluded that Embrace Pit and Fissure Sealant, Low Fill is substantially equivalent in design, composition, performance and intended use to the predicate products. The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3765 and have been used by dental professionals for more than ten years with no reports of adverse events.

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Image /page/2/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 swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

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

MAR 2 1 2012

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

Re: K113818

Trade/Device Name: Embrace" Wetbond™ Pit and Fissure Sealant, Low Fill Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Codes: EBC Dated: December 21, 2011 Received: December 30, 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 foc

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 (if known):

Device Name: Pulpdent Embrace™ WetBond™ Pit and Fissure Sealant, Low Fill

## Indications For Use:

Embrace Pit and Fissure Sealant, Low Fill is a professional dental material, designed with no Bisphenol A, that contains fluoride releasing, light cured, glass-filled acrylate resins and is less than 10% filled. Embrace Pit and Fissure Sealant, Low Fill is available in two shades (tooth-colored and off-white) and is used to seal the pits and fissures in teeth.

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 Runai

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

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