Cleared Traditional

K963921 - PULPDENT SEAL-RITE UDMA
(FDA 510(k) Clearance)

K963921 · Pulpdent Corp. · Dental

Nov 1996

Decision

43d

Days

Class 2

Risk

K963921 is an FDA 510(k) clearance for the PULPDENT SEAL-RITE UDMA. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC).

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on November 12, 1996, 43 days after receiving the submission on September 30, 1996.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number	K963921 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 1996
Decision Date	November 12, 1996
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF