← Product Code KJJ · K032627 # ULTRADENT CITRIC ACID 10% SOLUTION (K032627) _Ultradent Products, Inc. · KJJ · Nov 12, 2003 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K032627 ## Device Facts - **Applicant:** Ultradent Products, Inc. - **Product Code:** KJJ - **Decision Date:** Nov 12, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use Ultradent Citric Acid 10% Solution is used just prior to obtigation to etch the canal walls, especially ape to allow optimum seal. ## Device Story Ultradent Citric Acid 10% Solution is a chemical root canal cleanser. Applied by dental professionals during endodontic procedures; used to etch canal walls prior to obturation. Purpose is to remove the smear layer to improve the seal between the root canal filling material and the dentin. Benefits include enhanced sealing of the root canal system, potentially reducing microleakage and improving long-term treatment success. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics 10% Citric Acid solution. Liquid form factor. Chemical etching agent. Standalone dental product. No electronic components or software. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the left. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 2 2003 Mr. Peter Allred R&D Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095 Re: K032627 Trade/Device Name: Ultradent Citric Acid 10% Solution Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: August 22, 2003 Received: September 09, 2003 Dear Mr. Allred: 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. {1}------------------------------------------------ Page 2 - Mr. Peter Allred 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 (OS) 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. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html Sincerely vours. Ques Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ (14032627 510(k) Number (if known): Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: Ultradent Citric Acid 10% Solution is used just prior to obtigation to etch the canal walls, especially ape to allow optimum seal. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI ## Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2 Susan Rupp Infection Control, D 510(k) Number: K030227 Page --- **Source:** [https://fda.innolitics.com/device/K032627](https://fda.innolitics.com/device/K032627) **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