Cleared Traditional

K070744 - NARROW NECK TEMPORARY COPING

K070744 is the FDA 510(k) clearance for NARROW NECK TEMPORARY COPING by Institut Straumann AG. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K070744 · Institut Straumann AG · Dental device
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Jun 2007
Decision
105d
Days
Class 2
Risk

K070744 is an FDA 510(k) clearance for the NARROW NECK TEMPORARY COPING. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Institut Straumann AG (Andover, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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.

View all Institut Straumann AG devices

Submission Details

510(k) Number K070744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2007
Decision Date June 29, 2007
Days to Decision 105 days
Submission Type Traditional
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
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K070744.
STRAUMANN P.004 RC GOLD ABUTMENT
K070549 · Institut Straumann AG · Aug 2007
STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS
K072071 · Institut Straumann AG · Aug 2007
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
K071585 · Straumann USA · Jul 2007
TITANIUM SCALLOPED ABUTMENT
K063768 · Vident · Jun 2007
WN SYNOCTA GOLD ABUTMENT
K063789 · Straumann USA · May 2007
STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING
K061277 · Straumann USA · Apr 2007