Cleared Traditional

K921571 - 1ST IMPRESSION

K921571 is an FDA 510(k) clearance for 1ST IMPRESSION, manufactured by Wykle Research, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 526-day FDA review.

K921571 · Wykle Research, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
526d
Days
Class 2
Risk

K921571 is an FDA 510(k) clearance for the 1ST IMPRESSION. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Wykle Research, Inc. (Carson City, US). The FDA issued a Cleared decision on September 10, 1993 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Wykle Research, Inc. devices

FDA 510(k) Submission Details - K921571

510(k) Number K921571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1992
Decision Date September 10, 1993
Days to Decision 526 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
399d slower than avg
Panel avg: 127d · This submission: 526d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 327
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K921571.
TREND SET 2 PLUS
K936070 · Confi-Dental Products Co. · Feb 1994
VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM
K930248 · Crown Delta Corp. · Jan 1994
EXA BITE REGISTRATION MATERIAL
K933206 · GC America, Inc. · Sep 1993
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993
VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD
K926033 · Harry J. Bosworth Co. · May 1993
TRIANGULAR JAW MICROLARYNGEAL FORCEPS
K925370 · Pilling Co. · Mar 1993