Cleared Traditional

K130485 - CONTROL SEAL

K130485 is an FDA 510(k) clearance for CONTROL SEAL, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K130485 · Voco GmbH · Dental device
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Feb 2014
Decision
351d
Days
Class 2
Risk

K130485 is an FDA 510(k) clearance for the CONTROL SEAL. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on February 11, 2014 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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. Elevated predicate reliance profile. 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 - K130485

510(k) Number K130485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2013
Decision Date February 11, 2014
Days to Decision 351 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
223d slower than avg
Panel avg: 128d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 118
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K130485.
HAPI Seal
K162598 · Bisco, Inc. · May 2017
Premier Sealant
K161580 · Premier Dental Company Products · Oct 2016
PACSEAL PIT & FISSURE SEALANT
K141717 · Pac-Dent International, Inc. · Mar 2015
PREVENT SEAL
K122521 · Itena Clinical · Jun 2013
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
K113818 · Pulpdent Corporation · Mar 2012
ULTRASEAL XT HYDRO
K112517 · Ultradent Products, Inc. · Sep 2011
K130485 · CONTROL SEAL
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