Cleared Traditional

K900510 - PERTAC-HYBRID

K900510 is an FDA 510(k) clearance for PERTAC-HYBRID, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K900510 · Espe GmbH (Us) · Dental device
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Aug 1990
Decision
188d
Days
Class 2
Risk

K900510 is an FDA 510(k) clearance for the PERTAC-HYBRID. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 188 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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.

View all Espe GmbH (Us) devices

FDA 510(k) Submission Details - K900510

510(k) Number K900510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1990
Decision Date August 09, 1990
Days to Decision 188 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
61d slower than avg
Panel avg: 127d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 800
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K900510.
DEGUFILL (R) M
K901868 · Degussa AG · Aug 1990
DEGUFILL (R) H
K901869 · Degussa AG · Aug 1990
DEGUFILL (TM)
K902745 · Degussa AG · Aug 1990
DEGUFILL (R) ETCHANT
K901872 · Degussa AG · Aug 1990
DEGUFILL (TM) ETCHANT GEL
K902743 · Degussa AG · Aug 1990
HELIO PROGRESS (DENTAL COMPOSITE)
K901914 · Ivoclar North America, Inc. · Jun 1990