STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER— 510(k) K103158

Name: FDA 510(k) clearance K103158
Creator: U.S. Food and Drug Administration
Published: 2011-02-07

Substantially Equivalent

Angstrom Mfg., Inc.

FDA 510(k) clearance K103158 for STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER, Substantially Equivalent on 2011-02-07. Applicant: Angstrom Mfg., Inc.. Device class: 1.

Clearance details

Applicant: Angstrom Mfg., Inc.
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2010-10-26
Decision date: 2011-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomsdale, MO, US

Download summary PDF View on FDA.gov ↗

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K103157 — DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE2011-01-24

Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.