Cleared Traditional

K973289 - RE NU

K973289 is an FDA 510(k) clearance for RE NU, manufactured by Pacific Rim Dental, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 525-day FDA review.

K973289 · Pacific Rim Dental, Inc. · Dental device
Download Printable Device Report (PDF)
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Feb 1999
Decision
525d
Days
Class 1
Risk

K973289 is an FDA 510(k) clearance for the RE NU. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Pacific Rim Dental, Inc. (Stateline, US). The FDA issued a Cleared decision on February 9, 1999 after a review of 525 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Pacific Rim Dental, Inc. devices

FDA 510(k) Submission Details - K973289

510(k) Number K973289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1997
Decision Date February 09, 1999
Days to Decision 525 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
398d slower than avg
Panel avg: 127d · This submission: 525d
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 32
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K973289.
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