Cleared Traditional

K910813 - MET-ETCH

K910813 is an FDA 510(k) clearance for MET-ETCH, manufactured by Gresco Products, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K910813 · Gresco Products, Inc. · Dental device
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May 1991
Decision
70d
Days
Class 2
Risk

K910813 is an FDA 510(k) clearance for the MET-ETCH. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Gresco Products, Inc. (Stafford, US). The FDA issued a Cleared decision on May 7, 1991 after a review of 70 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 Gresco Products, Inc. devices

FDA 510(k) Submission Details - K910813

510(k) Number K910813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1991
Decision Date May 07, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
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 102
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K910813.
PIT AND FISSURE SEALANT PRODUCTS
K914319 · Confi-Dental Products Co. · Oct 1991
BARITONE C2 & BARITONE L3
K914322 · Confi-Dental Products Co. · Oct 1991
PULPDENT SEAL RITE
K911287 · Pulpdent Corp. · Jun 1991
DEGUFILL (TM) WHIT-SEALANT
K902742 · Degussa AG · Sep 1990
SEAL RITE(TM)
K902022 · Pulpdent Corp. · Jul 1990
SEAL RITE PROCEDURE KIT(TM)
K902023 · Pulpdent Corp. · Jul 1990