Cleared Traditional

K101756 - TSC

K101756 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
125d
Days
-
Risk

K101756 is an FDA 510(k) clearance for the TSC. Classified as Cord, Retraction (product code MVL).

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on October 26, 2010 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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 Kerr Corporation devices

FDA 510(k) Submission Details - K101756

510(k) Number K101756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2010
Decision Date October 26, 2010
Days to Decision 125 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
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 32
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K101756.
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
K113839 · Parkell, Inc. · Apr 2012
SULCUS BLUE
K111978 · Produits Dentaires Pierre Rolland · Oct 2011
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
K111348 · Centrix, Inc. · Jul 2011
GIRAFFE2
K102133 · Kerr Corporation · Oct 2010
COSP2
K093721 · 3M Espe AG Dental Products · Feb 2010
LIQUICORD
K092384 · Centrix, Inc. · Nov 2009