EMBRACE WETBOND CLEAR SEALANT

K052281 · Pulpdent Corporation · EBC · Feb 8, 2006 · Dental

Device Facts

• Record ID: K052281
• Device Name: EMBRACE WETBOND CLEAR SEALANT
• Applicant: Pulpdent Corporation
• Product Code: EBC · Dental
• Decision Date: Feb 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used to seal small defects such as buccal pits, lingual grooves or facial surface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.

Device Story

Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured dental material; used by dental professionals to seal pits, fissures, and small surface defects (buccal pits, lingual grooves); also functions as an orthodontic bracket coating. Material hardens upon light-curing to a clear finish. Applied in clinical dental settings. Benefits include protection of tooth surfaces and stabilization of orthodontic brackets. Substantial equivalence established via comparison to existing pit and fissure sealants.

Clinical Evidence

Bench testing only. Four studies on similar products with the same resin base evaluated penetration depth, marginal leakage, microleakage after thermal cycling, and abrasion resistance. Clinical performance study (O'Donnell, 2005) cited. Post-market surveillance of Pulpdent predicates over four years reported no serious complaints, failures, or patient injuries.

Technological Characteristics

Hydrophilic, light-cured resin-based dental sealant. Formulated for application to pits, fissures, and small defects. Material cures to a clear state. No specific ASTM standards cited.

Indications for Use

Indicated for use as a pit and fissure sealant, to seal small dental defects (buccal pits, lingual grooves, facial surface defects), and as an orthodontic bracket coating.

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™ Pit and Fissure Sealant
• Dentsply Delton Clear
• Pulpdent Embrace™ Seal-n-Shine
• Bisco BisCover
• Cosmedent CosmeSeal

Submission Summary (Full Text)

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510 k Premarket Notification K052281 2008 FEB 8 EMBRACE™ WETBOND™ CLEAR SEALANT

# EXHIBIT 2 (REVISED)

# SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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

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

DEVICE NAME: Embrace™ WetBond™ Clear Sealant

## PREDICATE DEVICES:

| Pulpdent Embrace™ Pit and Fissure Sealant | Dentsply Delton Clear |
|-------------------------------------------|-----------------------|
| Pulpdent Embrace™ Seal-n-Shine | Bisco BisCover |
| | Cosmedent CosmeSeal |

## DESCRIPTION AND INTENDED USE:

Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used small defects such as puch pins, lingual grooves or facial sufface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.

# COMPARISON WITH PREDICATE PRODUCTS:

Embrace™ WetBond™ Clear Sealant is substantially equivalent in design, composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.

#### SAFETY AND EFFECTIVENESS:

Pulpdent Embrace™ WetBond™ Clear Sealant 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. Dences under 872.3310 or 872.3765. The chemical in Embrace™ WetBond™ Clear Sealant are the same as those used in the Pulpdent predicate products and equivalent to those used in the other products.

Four studies, carried out on similar products with the same Embrace™ WetBond™ resin base, demonstrate the effectiveness of Embrace™ WetBond™ materials.

- Penetration depth and marginal leakage of Embrace™ WetBond™ Pit and Fissure Sealant and Small Lesion Restorative Material. Professor Michael DeGrange, Biomaterials Innovations Research Development Laboratory, Paris, France. 2001, 2002.
- * Microleakage of surface sealants in Class V restorations after thermal cycling. Pulpdent Corporation.
- * In vitro study on toothpaste / toothbrush abrasion resistance of a new dental material: Seal-n-Shine. Pulpdent Corporation.
- · Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant. Dr. JP O'Donnell. 2005.

There is no ISO or ANSIIADA standard applicable to Embrace™ Clear Sealant. Laboratory testing has shown that Embrace™ WetBond™ Clear Sealant Is equivalent in physical and mechanical properties to the predicate products. Four years of post-market surveillance of the two Pulpdent predicate has demonstrated only positive feedback from our customers. There have been no serious complaints or failures and no injuries to patients or dental professionals. According to the NIH Technology Assessment Conference and Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...Both composites and glass ionomers are relatively trouble-fraour is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually hillions of procedures in the United States."

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 8

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

Re: K052281

Trade/Device Name: Embrace™ WetBond™ Clear Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC, EBD Dated: January 31, 2006 Received: February 6, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Serita Y. Michael Davis

Chiu Lin, Ph.D. 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: K052281

Device Name: Embrace™ WetBond™ Clear Sealant

Indications for Use:

Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used to seal small defects such as buccal pits, lingual grooves or facial surface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.

Prescription Use
(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)

Sven Russo

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ാ വില്ലിപ്പോൾന്മൃ. General Hospit Joh Control. Dental Devices

K(5522)X