Cleared Traditional

K935152 - DENTAURUM DENTAFORM BANDS

K935152 is an FDA 510(k) clearance for DENTAURUM DENTAFORM BANDS, manufactured by Dentauraum, Inc.. The device is a Class 1 Dental device with product code DYO cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K935152 · Dentauraum, Inc. · Dental device
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Jan 1994
Decision
95d
Days
Class 1
Risk

K935152 is an FDA 510(k) clearance for the DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD. Classified as Band, Material, Orthodontic (product code DYO), Class I - General Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on January 31, 1994 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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 Dentauraum, Inc. devices

FDA 510(k) Submission Details - K935152

510(k) Number K935152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date January 31, 1994
Days to Decision 95 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
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

DYO Device Classification - Class 1, General Controls

Product Code DYO Band, Material, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
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.