Cleared Traditional

K964430 - PULPDENT SNOOP
(FDA 510(k) Clearance)

K964430 · Pulpdent Corp. · Dental

Jan 1997

Decision

73d

Days

Class 2

Risk

K964430 is an FDA 510(k) clearance for the PULPDENT SNOOP. This device is classified as a Device, Caries Detection (Class II — Special Controls, product code LFC).

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on January 17, 1997, 73 days after receiving the submission on November 5, 1996.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1740.

Submission Details

510(k) Number	K964430 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 1996
Decision Date	January 17, 1997
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement