Cleared Traditional

K103550 - YOBOSHI DENTAL UNIT

K103550 is an FDA 510(k) clearance for YOBOSHI DENTAL UNIT, manufactured by Fosham Yoboshi Medical Equipment Co., Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K103550 · Fosham Yoboshi Medical Equipment Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
32d
Days
Class 1
Risk

K103550 is an FDA 510(k) clearance for the YOBOSHI DENTAL UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Fosham Yoboshi Medical Equipment Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on January 4, 2011 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Fosham Yoboshi Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K103550

510(k) Number K103550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2010
Decision Date January 04, 2011
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 112
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K103550.
S200, S300
K133412 · Cefla S.C. · Jan 2015
CS 1200
K112321 · Carestream Health, Inc. · Nov 2011
AMC-20 PORTABLE DENTAL CART MODEL AMC-20
K101332 · Aseptico, Inc. · Apr 2011
A-DEC 200 DENTAL SYSTEM
K102234 · A-Dec, Inc. · Nov 2010
STERN'S S250 NORDAM
K092917 · Cefla S.C. · Jun 2010
KODAK 1500 INTRAORAL CAMERA
K091186 · Carestream Health, Inc. · Aug 2009