Cleared Traditional

K821221 - DENTAL IMPRESSION MATERIAL

K821221 is an FDA 510(k) clearance for DENTAL IMPRESSION MATERIAL, manufactured by Crown Delta Corp.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K821221 · Crown Delta Corp. · Dental device
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Jun 1982
Decision
41d
Days
Class 2
Risk

K821221 is an FDA 510(k) clearance for the DENTAL IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Crown Delta Corp. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1982 after a review of 41 days - a notably fast clearance cycle.

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: 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 Crown Delta Corp. devices

FDA 510(k) Submission Details - K821221

510(k) Number K821221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date June 07, 1982
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
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 265
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K821221.
PERFOURM
K842324 · Cutter Laboratories, Inc. · Nov 1984
TWO COMPONENT RTV VINYL SILICONE MATER
K843145 · Crown Delta Corp. · Oct 1984
ODONTIC CENTRIC(BITE) REGIST. PASTE
K830044 · Wallace A. Erickson & Co. · Apr 1983
SYBRON/KERR MIRROR 3
K820183 · Sybron Corp. · Feb 1982
EXAFLEX IMPRESSION MATERIAL
K812406 · G-C Intl. Corp. · Oct 1981
G-C FIT-CHECKER IMPRESSION MATERIAL
K812679 · G-C Intl. Corp. · Oct 1981