← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K032953 # EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT (K032953) _Pulpdent Corporation · KLE · Dec 10, 2003 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K032953 ## Device Facts - **Applicant:** Pulpdent Corporation - **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md) - **Decision Date:** Dec 10, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3200 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use Embrace™ WetBond™ Restoration & PFM Repair Kit is a convenience kit used by the dentist to repair restorations. The components were designed for bonding to all restorative, metal and ceramic surfaces, including precious and non-precious metals, porcelain and enamel. The kit provides materials for preparing, priming, opaquing and protecting surfaces, and for sealing, finishing and polishing the final repair or restoration. ## Device Story Embrace™ WetBond™ Restoration & PFM Repair Kit is a dental convenience kit used by dentists in a clinical setting to repair existing dental restorations. The kit contains various chemical components designed for surface preparation, priming, opaquing, and protecting, as well as sealing, finishing, and polishing. The dentist applies these materials manually to the damaged restoration, metal, or ceramic surface to facilitate bonding and restoration. The device benefits the patient by enabling the repair of existing dental work, thereby extending the functional life of the restoration. ## Clinical Evidence No clinical data. Substantial equivalence is supported by laboratory testing of mechanical properties and comparison to established dental materials with a long history of safe use. ## Technological Characteristics Convenience kit containing chemical components for dental bonding, priming, and sealing. Materials are consistent with established dental restorative agents. No specific ISO or ANSI/ADA standards are applicable. The device is a manual, non-powered dental material system. ## Regulatory Identification A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. ## Predicate Devices - Kuraray Clearfil Porcelain Repair Kit - Ultradent Porcelain Repair Kit - Ivoclar Vivadent Ceramic Repair Kit ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ KO 32953 PL LPDENT CORPORATION 510 k Premarket Notification Embrace™ WetBond™ Restoration & PFM Repair Kit #### EXHIBIT 2 ### SUMMARY OF SAFETY AND EFFECTIVENESS DATA Kenneth J. Berk 8 ) Oakland Street FO Box 780 V/atertown, MA 02472 USA 617-926-6666 Telephone: 617-926-6262 Fax: Email: Pulpdent@pulpdent.com #### Embrace™ WetBond™ Restoration & PFM Repair Kit DEVICE: NAME: I'REDICATE DEVICES: Kuraray Clearfil Porcelain Repair Kit Ultradent Porcelain Repair Kit Ivoclar Vivadent Ceramic Repair Kit Components of the Embrace™ WetBond™ Restoration & PFM Kit Pulodent Embrace First Coat Pulodent Embrace Seal-n-Shine Pulpdent Embrace Opaquer Pulpdent Kool-Dam Pulpdent Porcelain Etch Gel #### DESCRIPTION AND INTENDED USE: Embrace™ WetBond™ Restoration & PFM Repair Kit is a convenience kit used by the dentist to repair restorations. The components were designed for bonding to all restorative, metal and ceramic restorations: The 'oumpensite' include tor preparing, priming, opaquing and protecting surfaces, and for sealing, finishing and polishing the final repair or restoration. #### COMPARISON WITH PREDICATE PRODUCTS: Embrace™ WetBond™ Restoration & PFM Repair Kit is substantially equivalent in design, composition and intended use to the kits listed above. The component material Restoration & PFM Repair Kit have been found to be substantially equivalent under the 510(k) premarket notification process. Please see Exhibit 4 for the entire comparison. #### SAFETY AND EFFECTIVENESS: Embrace™ WetBond™ Restoration & PFM Repair Kit is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate listed above. The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3200. The chemical ingredients used in Embrace™ WetBond™ Restoration & PFM Repair Kit are used in the r Fre cremiou in the established dental materials. Though there is no ISO or ANS/ADA standard aplicable to Embrace " Welfond" (Restrailor & PFM Repair Kit, laboratory testin mechanical properties to the predicate products. According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Aoording to the high - "General usage of these materials over about 20 years indicates a high benefitto-risk ratio. There is no evidence of short-term or long-term risk. There is no suspicion of any problems after virtually billions of procedures in the United States." {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 0 2003 Mr. Kenneth J. Berk Director, Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472 Re: K032953 Trade/Device Name: Embrace™ WetBond ™ Restoration & PFM Repair Kit Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 10, 2003 Received: September 22, 2003 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. {2}------------------------------------------------ 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html Sincerely yours, Carls 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 {3}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT K032953 510 (k) Number (if known) Device Name # Embrace ™ WetBond ™ Restoration & PFM Repair Kit ### Indications for Use: Indications for USe. Embrace ™ WetBond ™ Restoration & PFM Repair Kit is a convenience kit used by the all WetBond The liness The components were, designed for bonding Embrace ™ WetBond "" Restoration & PFM Repair Tor is a osh only of on all dentists to repair restorations. The components were designed for all e repair dentists to repair restorations. The components and non-precious and non-precious metals, restorative, metal and ceramic surfaces, including precious and non-precious metals, restorative, metal and ceramic surfaces, including precious and non-protect, opaque, prime, provides materials and restorative materials, porcelain and enamel: The Rit provides and restorative materials. Susan Runn (Division Sign-Division of Anesthesiology, General Hospital, Infection Control, Dental De 510(k) Number: K083215 Please do not write below this line. Continue on another page if needed. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use or --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K032953](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K032953) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com