Cleared Traditional

K892937 - REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS (FDA 510(k) Clearance)

K892937 · Dentsply Intl. · Orthopedic device

Jun 1989

Decision

62d

Days

Class 1

Risk

K892937 is an FDA 510(k) clearance for the REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS. This device is classified as a Mixer, Cement, For Clinical Use (Class I - General Controls, product code JDZ).

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 22, 1989, 62 days after receiving the submission on April 21, 1989.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4210.

Submission Details

510(k) Number	K892937 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 21, 1989
Decision Date	June 22, 1989
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—