Cleared Traditional

DENTAL PROPHY CUPS (VARIOUS TYPES)

K864059 · Mission White Dental, Inc. · Dental

Nov 1986

Decision

30d

Days

Class 1

Risk

About This 510(k) Submission

K864059 is an FDA 510(k) clearance for the DENTAL PROPHY CUPS (VARIOUS TYPES), a Cup, Prophylaxis (Class I — General Controls, product code EHK), submitted by Mission White Dental, Inc. (Tinton Falls, US). The FDA issued a Cleared decision on November 19, 1986, 30 days after receiving the submission on October 20, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.6290.

Submission Details

510(k) Number	K864059 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 1986
Decision Date	November 19, 1986
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—