Branemark System Drill Controller

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K931785 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Branemark System 17 Angulated Abutment

  Class II

  FDA 510(k) K944962 Active Cleared 27 Feb 1995

• Branemark System

  Class II

  FDA 510(k) K934825 Active Cleared 8 Aug 1994

• Branemark System Estheticone Abutment Complete

  Class II

  FDA 510(k) K925777 Active Cleared 14 Apr 1993

• Branemark System-3.0mm Fixture

  Class II

  FDA 510(k) K911960 Active Cleared 19 Dec 1991

• Miruscone Abutment System

  Class II

  FDA 510(k) K961728 Active Cleared 10 Jul 1996

• Branemark System Single Tooth Abutments, Inst&Comp.

  Class II

  FDA 510(k) K925767 Active Cleared 20 Oct 1993

See all devices from Nobelpharma USA, Inc. →

• What is the primary purpose of the Branemark System Drill Controller in dental implant procedures?

  The Branemark System Drill Controller is designed to regulate and control the drilling process during osseointegrated implant placement. It ensures precise depth control and consistent drilling parameters, which are critical for accurately preparing bone sites according to the Branemark System protocol. This helps maintain uniformity and safety during implant surgery.

• Is the Branemark System Drill Controller intended for single-use or can it be reused after sterilization?

  The device is explicitly described as a reusable component integrated into the Branemark System. Since it is not sterile upon packaging, it must undergo proper sterilization procedures before each use in a clinical setting. There are no claims of single-use in the regulatory data.

• How is the Branemark System Drill Controller regulated in the U.S., and what does that mean for its use?

  The device holds an FDA 510(k) clearance (K931785) and is classified as a Class II medical device. This means it has undergone a review by the FDA’s Dental (DE) Advisory Committee to confirm it is *substantially equivalent* to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for dental drilling applications.

• What type of clinical settings is the Branemark System Drill Controller intended for?

  The device is explicitly intended for use in *clinical dental settings* where osseointegrated implant procedures are performed. Its design and regulatory classification align with professional dental environments where precision drilling for implant placement is required.