Cleared Traditional

K901097 - FILLOCK REAMER

K901097 is an FDA 510(k) clearance for FILLOCK REAMER, manufactured by Ivoclar North America, Inc.. The device is a Class 1 Dental device with product code DZA cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K901097 · Ivoclar North America, Inc. · Dental device
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Apr 1990
Decision
49d
Days
Class 1
Risk

K901097 is an FDA 510(k) clearance for the FILLOCK REAMER. Classified as Drill, Dental, Intraoral (product code DZA), Class I - General Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on April 25, 1990 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4130 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ivoclar North America, Inc. devices

FDA 510(k) Submission Details - K901097

510(k) Number K901097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date April 25, 1990
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

DZA Device Classification - Class 1, General Controls

Product Code DZA Drill, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4130
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 - DZA Drill, Dental, Intraoral

Devices cleared under the same product code (DZA) and FDA review panel - the closest regulatory comparables to K901097.
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