← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K971121 # ENCORE BOND (K971121) _Centrix, Inc. · KLE · Jun 27, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K971121 ## Device Facts - **Applicant:** Centrix, Inc. - **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md) - **Decision Date:** Jun 27, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3200 - **Device Class:** Class 2 - **Review Panel:** Dental ## Intended Use ENCORE BOND is a self-cure bonding agent for dentin and enamel tooth surfaces. It is mixed and applied in a thin coating to etched tooth surfaces, to achieve bonding of self-cure composite resins to tooth structure. ## Device Story Encore Bond is a self-cure dental bonding agent; applied as a thin coating to etched dentin and enamel surfaces; functions to facilitate adhesion between tooth structure and self-cure composite resins; used in dental clinical settings by licensed dental professionals; provides a chemical interface to improve restorative material retention; benefits patient by enhancing longevity and stability of dental composite restorations. ## Clinical Evidence Bench testing only. ## Technological Characteristics Self-cure dental bonding agent; chemical composition designed for application to etched dentin and enamel; liquid form factor; intended for professional dental use. ## 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. ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. John Discko Executive Vice President Centrix Incorporated 770 River Road Shelton, Connecticut 06484-5458 JUN 27 1997 Re: K971121 Trade Name: Encore Bond Regulatory Class: II Product Code: KLE Dated: April 24, 1997 Received: April 29, 1997 Dear Mr. Discko: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1} Page 2 - Mr. Discko through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} 08/27/96 TUE 10:08 FAX 301 480 3002 FDA/ODE/DDIGD 002 Page ___ of ___ 510(k) Number (if known): K971121 Device Name: ENCORE BOND Indications For Use: ENCORE BOND is a self-cure bonding agent for dentin and enamel tooth surfaces. It is mixed and applied in a thin coating to etched tooth surfaces, to achieve bonding of self-cure composite resins to tooth structure. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runner (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K971121 Prescription Use ___ OR Over-The-Counter Use No (Per 21 CFR 801.109) (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K971121](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K971121) **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