Cleared Traditional

K871270 - PERFORM DENTURE BASE RESIN

K871270 is an FDA 510(k) clearance for PERFORM DENTURE BASE RESIN, manufactured by Ipco Corp.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K871270 · Ipco Corp. · Dental device
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May 1987
Decision
59d
Days
Class 2
Risk

K871270 is an FDA 510(k) clearance for the PERFORM DENTURE BASE RESIN. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ipco Corp. (White Plains, US). The FDA issued a Cleared decision on May 29, 1987 after a review of 59 days - a notably fast clearance 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: 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 Ipco Corp. devices

FDA 510(k) Submission Details - K871270

510(k) Number K871270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date May 29, 1987
Days to Decision 59 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
68d faster than avg
Panel avg: 127d · This submission: 59d
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 792
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K871270.
CLEARFIL CORE NEW BOND
K871637 · Kuraray Co. · Jul 1987
CLEARFIL POSTERIOR 3
K871635 · Kuraray Co. · Jul 1987
SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER
K872279 · 3M Company · Jul 1987
ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM
K871295 · Johnson & Johnson Professionals, Inc. · May 1987
ESPE CHELON-SILVER
K865028 · Espe GmbH (Us) · Feb 1987
REMBRANDT PORCELAIN TINTING KIT
K864346 · Den-Mat Corp. · Jan 1987