Cleared Traditional

K032925 - B&R DEVICE

K032925 is an FDA 510(k) clearance for B&R DEVICE, manufactured by Ronvig A/S. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K032925 · Ronvig A/S · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
91d
Days
Class 1
Risk

K032925 is an FDA 510(k) clearance for the B&R DEVICE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Ronvig A/S (Daugaard, DK). The FDA issued a Cleared decision on December 22, 2003 after a review of 91 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.

FDA 510(k) Submission Details - K032925

510(k) Number K032925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date December 22, 2003
Days to Decision 91 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
37d faster than avg
Panel avg: 128d · This submission: 91d
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 67
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K032925.
DR DISPOSABLE PROPHY ANGLE MODEL H310
K060377 · Dental Resources · Apr 2006
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
K051077 · Aseptico, Inc. · May 2005
AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
K042171 · Micro-Mega Societe Anonyme · Nov 2004
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
K022505 · NOUVAG AG · Oct 2003
PROANGLE DISPOSABLE PROPHY ANGLE
K030603 · Pac-Dent International (Suzhou), Ltd. · Apr 2003
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
K023953 · St. George Technology, Inc. · Feb 2003
K032925 · B&R DEVICE
Download PDF Ronvig A/S