Cleared Traditional

K061535 - GC XLC-100 CAPSULE

K061535 is the FDA 510(k) clearance for GC XLC-100 CAPSULE by GC America, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K061535 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
42d
Days
Class 2
Risk

K061535 is an FDA 510(k) clearance for the GC XLC-100 CAPSULE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on July 14, 2006 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GC America, Inc. devices

Submission Details

510(k) Number K061535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2006
Decision Date July 14, 2006
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K061535.
MERON PLUS
K063554 · Voco GmbH · Jan 2007
CLEARFIL ESTHETIC CEMENT & DC BOND
K062410 · Kuraray Medical, Inc. · Sep 2006
MULTILINK SPRINT
K061781 · Ivoclar Vivadent, Inc. · Sep 2006
BISCEM TRANSLUCENT, BISCEM OPAQUE
K060701 · Bisco, Inc. · May 2006
BIFIX QM
K060894 · Voco GmbH · May 2006
GI DENTSTAT
K060334 · Ultradent Products, Inc. · Feb 2006