Cleared Traditional

K954281 - PANASIL IMPRESSION MATERIAL

K954281 is an FDA 510(k) clearance for PANASIL IMPRESSION MATERIAL, manufactured by Roydent Dental Products, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K954281 · Roydent Dental Products, Inc. · Dental device
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Jun 1996
Decision
285d
Days
Class 2
Risk

K954281 is an FDA 510(k) clearance for the PANASIL IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Roydent Dental Products, Inc. (Rochester Hills, US). The FDA issued a Cleared decision on June 24, 1996 after a review of 285 days - an extended review 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: 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 Roydent Dental Products, Inc. devices

FDA 510(k) Submission Details - K954281

510(k) Number K954281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1995
Decision Date June 24, 1996
Days to Decision 285 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 127d · This submission: 285d
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 288
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K954281.
HYUNJAE DENTAL IMPRESSION MATERIALS
K962680 · Hyunjae Corp. · Sep 1996
TRI-PHASIX CHROMATIC ALGINATE
K962741 · Parkell, Inc. · Sep 1996
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · Dentsply Intl. · Aug 1996
BOSWORTH IMPRESSION MATERIAL II
K961201 · Harry J. Bosworth Co. · May 1996
DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE
K960547 · Espe GmbH & Co. Kg. · Mar 1996
EXAFLEX IMPRESSION MATERIAL (MODIFICATION)
K955932 · GC America, Inc. · Mar 1996