Cleared Traditional

K071352 - CERADRILL

K071352 is an FDA 510(k) clearance for CERADRILL, manufactured by Gebr. Brasseler GmbH & Co. KG. The device is a Class 1 Dental device with product code EJL cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K071352 · Gebr. Brasseler GmbH & Co. KG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
45d
Days
Class 1
Risk

K071352 is an FDA 510(k) clearance for the CERADRILL. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by Gebr. Brasseler GmbH & Co. KG (Lemgo, DE). The FDA issued a Cleared decision on June 29, 2007 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3240 - 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.

FDA 510(k) Submission Details - K071352

510(k) Number K071352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2007
Decision Date June 29, 2007
Days to Decision 45 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 128d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EJL Device Classification - Class 1, General Controls

Product Code EJL Bur, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3240
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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EJL Bur, Dental

All 10
Devices cleared under the same product code (EJL) and FDA review panel - the closest regulatory comparables to K071352.
SMARTBURS
K080687 · S.S. White Burs, Inc. · Jun 2008
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
K061383 · B.T.I. Biotechnology Institute, Sl. · Aug 2006
TRI HAWK BUR, FG BUR
K943273 · Tri Hawk Corp. · Aug 1994
MONOSTERYL
K926205 · Utensili Super Abrasivi · Feb 1994
DENTAL OR SURGICAL BUR
K923883 · Stratum Dental Technologies, Inc. · Jul 1993
DIAMONDS BURS-COMPOSIT FINISHING
K854690 · Almore Intl., Inc. · Mar 1986