Cleared Traditional

K771325 - NIMETIC ETCHING GEL

K771325 is an FDA 510(k) clearance for NIMETIC ETCHING GEL, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K771325 · Espe GmbH (Us) · Dental device
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Aug 1977
Decision
15d
Days
Class 2
Risk

K771325 is an FDA 510(k) clearance for the NIMETIC ETCHING GEL. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Mchenry, US). The FDA issued a Cleared decision on August 2, 1977 after a review of 15 days - a notably fast clearance cycle.

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: 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 Espe GmbH (Us) devices

FDA 510(k) Submission Details - K771325

510(k) Number K771325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1977
Decision Date August 02, 1977
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

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 381
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K771325.
PRISMA-BOND
K801093 · Dentsply Intl. · May 1980
VISIO-BOND
K790833 · Espe GmbH (Us) · Apr 1979
UVIOBOND
K771328 · Espe GmbH (Us) · Aug 1977
NIMETIC BONDING MATERIAL
K771326 · Espe GmbH (Us) · Aug 1977
BONDING AGENT, VYTOL
K760400 · L.D. Caulk Co. · Aug 1976
BONDING AGENT, PRESTIGE
K760324 · Lee Pharmaceuticals · Aug 1976