Irrigated Drill for SS Submerged Screw Plant

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K894151 ↗

FDA Product Code

DZJ

Device Class

Class II

Regulation

21 CFR Part 872.4120

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Artech Type Ss Submerged Screw Implant

  Class II

  FDA 510(k) K891346 Active Cleared 21 Dec 1989

• Artech Type Ss-Ha Submerged Screw Implant

  Class II

  FDA 510(k) K895267 Active Cleared 10 Apr 1990

• Hand Tools for Artech Type Ss Submerged Screw Impl

  Class II

  FDA 510(k) K894160 Active Cleared 28 Sep 1989

• Counterbore for Ss Submerged Screw Plant

  Class II

  FDA 510(k) K894150 Active Cleared 27 Sep 1989

• Artech Ardent IV - Type Clylinder Implant

  Class II

  FDA 510(k) K911735 Active Cleared 5 Mar 1992

• Tps Screw Dental Implants

  Class II

  FDA 510(k) K843218 Active Cleared 27 Sep 1984

See all devices from Artech Corp. →

• Is this irrigated drill designed for single-use or can it be reused in multiple procedures?

  This irrigated drill is supplied as a reusable instrument, meaning it is intended to be cleaned, sterilized, and reused for multiple procedures. Since it is classified under FDA regulation 872.4120 and marked as non-sterile, proper reprocessing protocols must be followed to ensure safety and functionality between uses.

• What types of dental procedures is this irrigated drill specifically intended for?

  This device is specifically designed for submerged screw dental implants, where precise bone preparation is required. The irrigation feature helps reduce heat and debris during drilling, making it ideal for procedures involving bone drilling in dental applications.

• How is this device supplied, and what should I consider for storage?

  The irrigated drill is supplied as a non-sterile, reusable instrument, meaning it must be sterilized before first use and after each procedure. Since it is reusable, proper storage in a clean, dry environment—preferably in a sealed container or packaging—to prevent contamination is essential. Follow manufacturer guidelines for reprocessing and storage to maintain its integrity.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?

  This device received FDA 510(k) clearance under K894151, which means it was determined to be substantially equivalent to a legally marketed predicate device. The clearance was granted by the Dental (DE) Advisory Committee under the traditional review pathway, ensuring it meets FDA standards for safety and effectiveness in dental applications, particularly for submerged screw implants.