Cleared Traditional

K102207 - FIBER FORCE

K102207 is an FDA 510(k) clearance for FIBER FORCE, manufactured by Synca Marketing, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K102207 · Synca Marketing, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
110d
Days
Class 2
Risk

K102207 is an FDA 510(k) clearance for the FIBER FORCE. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Synca Marketing, Inc. (Houston, US). The FDA issued a Cleared decision on November 23, 2010 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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.

FDA 510(k) Submission Details - K102207

510(k) Number K102207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2010
Decision Date November 23, 2010
Days to Decision 110 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
18d faster than avg
Panel avg: 128d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 303
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K102207.
VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS
K102640 · Vertex-Dental B.V. · Mar 2011
IVOBASE HYBRID, IVOBASE HIGH IMPACT
K103391 · Ivoclar Vivadent, Inc. · Feb 2011
VERTEX RAPID SIMPLIFIED
K102654 · Vertex-Dental B.V. · Dec 2010
GRANDTEC
K102347 · Voco GmbH · Oct 2010
JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD
K100653 · Lang Dental Mfg. Co., Inc. · Oct 2010
TOKUYAMA TISSUECARE
K081554 · Tokuyama Dental Corporation · Mar 2009
K102207 · FIBER FORCE
Download PDF FDA Summary Synca Marketing, Inc.