Medevx

Medical Device Information Database

One-Fil

Device Information

One-Fil

One-Fil is a premixed, injectable calcium silicate composition used in root canal treatments. It requires water to set and harden. The device includes a syringe, plunger, disposable tips, and a holder for easy application. Its radiopaque material helps in precise dental imaging.

Indications

One-Fil is intended for the permanent sealing of root canals. It is designed to harden upon contact with moisture from dentin tubules during dental procedures.

Intended Use

One-Fil is for prescription use only and is intended for dental professionals to use during root canal treatments to seal the canal permanently.

Availability

Prescription only.

Study Results

Nonclinical Testing: One-Fil underwent ISO 6876 standard performance tests, including flow, setting time, and solubility. Additional biocompatibility tests following ISO 10993 standards were performed. Results confirmed the device’s safety and effectiveness.

Regulatory Information

  • Regulation Number: 21 CFR 872.3820
  • Regulatory Class: Class II
  • Product Code: KIF
  • 510(k) Number: K232182

One-Fil must comply with ISO 6876 standards and ISO 10993 for biocompatibility. Under the FDA’s dental device regulations, it is classified as a Class II device.

Manufacturer Information

  • Name: Mediclus Co., Ltd.
  • Address: No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea
  • Contact Person: Priscilla Chung (Regulatory Affairs Consultant, LK Consulting Group USA, Inc.)

Predicate Device Information

  • Primary Predicate Device: Well-Root ST (K170950) by VERICOM Co., Ltd.
  • Comparison: Both devices are used for the permanent sealing of root canals and have similar compositions. The primary difference is that One-Fil uses a calcium silicate compound, while the predicate device uses a calcium aluminosilicate compound. Both materials achieve similar outcomes in dental procedures.

Implications

One-Fil offers a permanent root canal sealing solution comparable to its predicate device. Extensive testing has demonstrated that its use of calcium silicate ensures biocompatibility and effectiveness.

References

  1. One-Fil. K232182. FDA summary link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232182
  2. http://mediclus.co.kr/
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