Cleared Traditional

K896071 - ULTRA II PORCELAIN POLISHING PASTE

K896071 is an FDA 510(k) clearance for ULTRA II PORCELAIN POLISHING PASTE, manufactured by Shofu Dental Corp.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K896071 · Shofu Dental Corp. · Dental device
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Aug 1990
Decision
299d
Days
Class 1
Risk

K896071 is an FDA 510(k) clearance for the ULTRA II PORCELAIN POLISHING PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Shofu Dental Corp. (Menlo Park, US). The FDA issued a Cleared decision on August 14, 1990 after a review of 299 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Shofu Dental Corp. devices

FDA 510(k) Submission Details - K896071

510(k) Number K896071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date August 14, 1990
Days to Decision 299 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 127d · This submission: 299d
Pathway characteristics
Predicate-based equivalence.

EJR Device Classification - Class 1, General Controls

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EJR Agent, Polishing, Abrasive, Oral Cavity

All 34
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K896071.
ABUTMENT GLO
K905303 · Implant Innovations International, Inc. · Jun 1991
PULPDENT DIAMOND POLISH
K911284 · Pulpdent Corp. · May 1991
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990
DEGUFILL (R) POLISHING GEL
K901873 · Degussa AG · Aug 1990
PULPDENT OIL FREE SURFACE PREPARATION PASTE
K901052 · Pulpdent Corp. · Apr 1990
KEN'S PROPHY GEL - REGULAR
K896661 · Pulpdent Corp. · Feb 1990