Cleared Traditional

K101485 - ALL-ETCH

Also marketed or referenced as:
UNI- ETCH, UNI- ETCH WITH BAC ETCH- 37, ETCH- 37 WITH BAC DARK- ETCH, DARK ETCH (BLUE- E

K101485 is the FDA 510(k) clearance for ALL-ETCH by Bisco, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K101485 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
90d
Days
Class 2
Risk

K101485 is an FDA 510(k) clearance for the ALL-ETCH, ALL- ETCH WITH BAC. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 26, 2010 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Bisco, Inc. devices

Submission Details

510(k) Number K101485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2010
Decision Date August 26, 2010
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 227
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K101485.
BEAUTIBOND MULTI
K110235 · Shofu Dental Corp. · May 2011
BEAUTIBOND MULTI PR PLUS
K110252 · Shofu Dental Corp. · May 2011
ALL-BOUND 3
K102844 · Bisco, Inc. · Oct 2010
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
K100752 · Ultradent Products, Inc. · Jul 2010
EXCITE F AND EXCITE DSC
K093744 · Ivoclar Vivadent, Inc. · Mar 2010
PRIMER PLUS
K091705 · Bisco, Inc. · Aug 2009