Cleared Traditional

K955892 - HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY

K955892 is an FDA 510(k) clearance for HYDROCOLLOID TRAY MATERIALS, manufactured by Van R Dental Products, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K955892 · Van R Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
68d
Days
Class 2
Risk

K955892 is an FDA 510(k) clearance for the HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCO.... Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Van R Dental Products, Inc. (Oxnard, US). The FDA issued a Cleared decision on March 5, 1996 after a review of 68 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 Van R Dental Products, Inc. devices

FDA 510(k) Submission Details - K955892

510(k) Number K955892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1995
Decision Date March 05, 1996
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
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 K955892.
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
BOSWORTH IMPRESSION MATERIAL I
K960063 · Harry J. Bosworth Co. · Feb 1996
SCAN WHITE 12 ML
K955406 · Vident · Dec 1995
DEGUPRINT
K955465 · Degussa Corp. · Dec 1995