Cleared Special

K070084 - MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL

K070084 is an FDA 510(k) clearance for MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL, manufactured by Est. Anthogyr. The device is a Class 1 Dental device with product code EFA cleared through the Special 510(k) pathway after a 58-day FDA review.

K070084 · Est. Anthogyr · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
58d
Days
Class 1
Risk

K070084 is an FDA 510(k) clearance for the MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by Est. Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on March 8, 2007 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070084

510(k) Number K070084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2007
Decision Date March 08, 2007
Days to Decision 58 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 128d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

EFA Device Classification - Class 1, General Controls

Product Code EFA Handpiece, Belt And/or Gear Driven, 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 - EFA Handpiece, Belt And/or Gear Driven, Dental

All 23
Devices cleared under the same product code (EFA) and FDA review panel - the closest regulatory comparables to K070084.
LOW & HIGH SPEED KIT
K090055 · Dpm USA Corp. · Oct 2009
STRONG IMPLANT HANDPIECES
K092412 · Saeshin Precision Co., Ltd. · Sep 2009
MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
K090676 · Anthogyr · May 2009
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)
K061701 · J. Morita USA, Inc. · Aug 2006
EXCEL HIGH SPEED DENTAL HANDPIECE
K061581 · Orthosource, Inc. · Aug 2006
IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES
K040674 · Anthogyr · Jun 2004
K070084 · MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
Download PDF FDA Summary Est. Anthogyr