Cleared Traditional

K061997 - PREMIER SELF-ETCHING ENAMEL SEALANT

K061997 is an FDA 510(k) clearance for PREMIER SELF-ETCHING ENAMEL SEALANT, manufactured by Premier Dental Products Co.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K061997 · Premier Dental Products Co. · Dental device
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Oct 2006
Decision
82d
Days
Class 2
Risk

K061997 is an FDA 510(k) clearance for the PREMIER SELF-ETCHING ENAMEL SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on October 4, 2006 after a review of 82 days - a notably fast clearance cycle.

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: 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 Premier Dental Products Co. devices

FDA 510(k) Submission Details - K061997

510(k) Number K061997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2006
Decision Date October 04, 2006
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
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 94
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K061997.
SPK SEALANT
K091632 · 3M Company · Sep 2009
INFILTRATION KIT
K081493 · Dmg USA, Inc. · Sep 2008
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
K062886 · CAO Group, Inc. · Nov 2006
GRANDIO SEAL
K062344 · Voco GmbH · Oct 2006
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
K061823 · Voco GmbH · Jul 2006
EMBRACE WETBOND CLEAR SEALANT
K052281 · Pulpdent Corporation · Feb 2006