Cleared Traditional

STRAIGHT HANDPIECE ADAPTER (K103158) - FDA 510(k) Clearance

Also marketed or referenced as:
CONTRA HANDPIECE ADAPTER TWIST HANDPIECE ADAPTER FLEX HANDPIECE ADAPTER

Class I Dental device.

K103158 · Angstrom Mfg., Inc. · Dental device
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Feb 2011
Decision
104d
Days
Class 1
Risk

K103158 is an FDA 510(k) clearance for the STRAIGHT HANDPIECE ADAPTER. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Angstrom Mfg., Inc. (Bloomsdale, US). The FDA issued a Cleared decision on February 7, 2011 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Angstrom Mfg., Inc. devices

Submission Details

510(k) Number K103158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2010
Decision Date February 07, 2011
Days to Decision 104 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 127d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 72
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