Cleared Traditional

K103157 - DISPOSABLE PROPHY ANGLE

Also marketed or referenced as:
DISPOSABLE PROPHY ANGLE

K103157 is an FDA 510(k) clearance for DISPOSABLE PROPHY ANGLE, manufactured by Angstrom Mfg., Inc.. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K103157 · Angstrom Mfg., Inc. · Dental device
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Jan 2011
Decision
90d
Days
Class 1
Risk

K103157 is an FDA 510(k) clearance for the DISPOSABLE PROPHY ANGLE. 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 January 24, 2011 after a review of 90 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

FDA 510(k) Submission Details - K103157

510(k) Number K103157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2010
Decision Date January 24, 2011
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

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 32
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K103157.
TI-MAX Z45
K121901 · Nakanishi, Inc. · Feb 2013
ENDO-EXPRESS (R) HANDPIECE
K111541 · Essential Dental Systems, Inc. · Mar 2012
TORQTECH
K103697 · J. Morita USA, Inc. · Jan 2012
STRONG DENTAL HANDPIECES
K100192 · Saeshin Precision Co., Ltd. · Feb 2010
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
K051077 · Aseptico, Inc. · May 2005
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
K020137 · Aseptico, Inc. · Mar 2002