Cleared Traditional

K993683 - PULPDENT UNO-DUO
(FDA 510(k) Clearance)

K993683 · Pulpdent Corp. · Dental

Dec 1999

Decision

42d

Days

Class 2

Risk

K993683 is an FDA 510(k) clearance for the PULPDENT UNO-DUO. This device is classified as a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE).

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on December 13, 1999, 42 days after receiving the submission on November 1, 1999.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K993683 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 1999
Decision Date	December 13, 1999
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF