Cleared Traditional

K093708 - TELIO CAD

K093708 is the FDA 510(k) clearance for TELIO CAD by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K093708 · Ivoclar Vivadent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
98d
Days
Class 2
Risk

K093708 is an FDA 510(k) clearance for the TELIO CAD. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on March 10, 2010 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K093708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2009
Decision Date March 10, 2010
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 89
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K093708.
STRUCTUR 3
K120779 · Voco GmbH · Jun 2012
PRO-V COAT
K103514 · Bisco, Inc. · May 2011
TELIO CS INLAY & TELIO CS ONLAY
K103379 · Ivoclar Vivadent, Inc. · Feb 2011
TEMPORARY C&B COMPOSITE
K091894 · Voco GmbH · Jul 2009
UNIFAST III
K073106 · GC America, Inc. · Apr 2008
ZENO PMMA DISC
K080182 · Wieland Dental + Technik GmbH & Co. KG · Apr 2008