Cleared Traditional

K960063 - BOSWORTH IMPRESSION MATERIAL I

K960063 is an FDA 510(k) clearance for BOSWORTH IMPRESSION MATERIAL I, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K960063 · Harry J. Bosworth Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
40d
Days
Class 2
Risk

K960063 is an FDA 510(k) clearance for the BOSWORTH IMPRESSION MATERIAL I. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 40 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 Harry J. Bosworth Co. devices

FDA 510(k) Submission Details - K960063

510(k) Number K960063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1996
Decision Date February 14, 1996
Days to Decision 40 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
87d faster than avg
Panel avg: 127d · This submission: 40d
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 K960063.
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
HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY
K955892 · Van R Dental Products, Inc. · Mar 1996
SCAN WHITE 12 ML
K955406 · Vident · Dec 1995
DEGUPRINT
K955465 · Degussa Corp. · Dec 1995
IMPREGUM PENTA
K954192 · Espe GmbH & Co. Kg. · Dec 1995