← Product Code LQY · K112508 # I-ROOT 100 (K112508) _S-Denti Co., Ltd. · LQY · Jun 19, 2012 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K112508 ## Device Facts - **Applicant:** S-Denti Co., Ltd. - **Product Code:** LQY - **Decision Date:** Jun 19, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE ## Intended Use The i-ROOT 100 is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures ## Device Story i-ROOT 100 is an electronic apex locator used by dental professionals to measure root canal length. The device consists of a main unit, lip clip, cable assembly, and file holders. It operates by measuring electrical impedance at specific frequencies (500 Hz and 5 kHz) to determine the position of the file tip within the root canal. The device provides visual feedback via a graph and audible feedback via a buzzer to indicate the proximity of the file to the apex. This information assists the clinician in accurately determining the working length during endodontic procedures, potentially improving the precision of root canal treatments. The device is powered by three 1.5V AA alkaline batteries. ## Clinical Evidence Bench testing only. Performance was verified through documented procedures compliant with ISO 9001, ISO 13485, and Medical Device Directives 93/42/EEC. Accuracy is specified at ±0.5mm. ## Technological Characteristics Electronic apex locator; uses 500 Hz and 5 kHz frequencies; patient auxiliary current <10 µA; accuracy ±0.5mm; power consumption <0.27VA; powered by 3x 1.5V AA alkaline batteries; includes main unit, lip clip, cable assembly, and file holders. ## Predicate Devices - i-ROOT ([K100450](/device/K100450.md)) ## 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}------------------------------------------------ ## JUN 1 9 2012 #### റ 510(k) Summary [as required by 807.92(c)] #### A. Applicant: -Company name: S-Denti Co.,Ltd -Address: Rm.607,612 Byucksan Digital Valley 6, 481-4, Gasan-dong, Geumcheon-gu, Seoul, 153-803, Korea Tel : +82-2-2627-3765~7 Fax : +82-2-2627-3768web : www.s-denti.com -Contact person: Peter Chung 412-687-3976 -Date: July 7th, 2011 B. Proprietary and Established Names: Trade Name: i-ROOT 100 Common Name:. Root Apex Locator Ragulation Name: Root Apex Locator Regulatory Classification: Unclassified, Dental, Product Code: LQY C. Predicate device: i- ROOT(K100450) #### D. Device Description i-ROOT 100 is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main unit and lip clip, Cable assembly and 2 kinds of File holder. #### E. Intended use The i-ROOT 100 is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures ### F. Technological Characteristics: The i-ROOT 100 is identical with predicate device in the following contents; Buzzer volume ,signal, Graph , Intended Use, Frequencies used(500 Hz ±0.2 Hz, 5 klz ±0.002 klz), Patient auxiliary current(less than AC 10 µA), Accuracy(±0.5mm) and Power consumption (less than 0.27VA) Difference is as follows; Predicate device(i-ROOT) uses the built-in rechargeable Lithium-ion batteries (4.1V x 2 pcs) and i-ROOT 100 uses the alkaline disposable batteries (1.5V AA x 3 pcs). #### G. Performance (Safety and Effectiveness Information) The production and inspection is followed by our documented procedures based on our quality systems - ISO 9001/ ISO 13485/ Medical Device Directives 93/42/EEC, which have been assessed by the third party certification bodies of SGS Certification. #### I. Conclusion: The performance tests demonstrated that i-ROOT 100 is as safe, as effective and performs in a substantially equivalent manner to the predicate device {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES 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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple, using a single color, and is designed to be easily recognizable. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ## JUN 1 9 2012 Ms. Tae K. Nam - President S-Denti Company. Limited Rm 607 Byucksan Digital Valley 6. 481-4 Gasan-Dong Geumcheon-Gu Tae Kye Nam Republic of Korea 153-803 Re: K112508 Trade/Device Name: i-ROOT 100 Electronic Apex Locator Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LQY Dated: May 26, 2012 Received: June 5, 2012 Dear Ms. Nam: 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. {2}------------------------------------------------ Page 2- Ms. Nam 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, for 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 {3}------------------------------------------------ Indications for Use Statement 4. # Indications for Use 510(k) Number (if known): K Electronic Apex Locator Device Name: i-ROOT 100 Indications For Use: The i-ROOT 100 is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures Prescription Use _ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) Swa Rusine Page 1 of (Division Sign-Off) rivision of Anesthesiology, General Hospital fection Control, Dental Devices 510(k) Number: k112508 --- **Source:** [https://fda.innolitics.com/device/K112508](https://fda.innolitics.com/device/K112508) **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