Tmj Cannula Set

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K871648 ↗

FDA Product Code

DZI

Device Class

Class II

Regulation

21 CFR Part 872.4120

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Aspen Laboratories, Inc. →

• What is the TMJ CANNULA SET used for?

  The TMJ CANNULA SET is a dental device specifically designed for use in temporomandibular joint procedures. It is classified as a Class II medical device intended for dental applications.

• What is the regulatory status of the TMJ CANNULA SET?

  The TMJ CANNULA SET has FDA 510(k) clearance with number K871648, cleared on June 8, 1987. It is regulated under product code DZI and was determined to be substantially equivalent to other devices on the market.

• Who manufactures the TMJ CANNULA SET?

  The TMJ CANNULA SET is manufactured by Aspen Laboratories, Inc., located in Englewood, CO. The company is responsible for supplying this dental device for temporomandibular joint procedures.

• What advisory committee reviewed the TMJ CANNULA SET?

  The TMJ CANNULA SET was reviewed by the Dental advisory committee (DE) as part of the FDA clearance process. This committee specializes in evaluating dental devices for safety and effectiveness.