Cleared Traditional

K991631 - FASTRAY LC

K991631 is an FDA 510(k) clearance for FASTRAY LC, 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 76-day FDA review.

K991631 · Harry J. Bosworth Co. · Dental device
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Optimized for regulatory review, auditing and printing
Jul 1999
Decision
76d
Days
Class 2
Risk

K991631 is an FDA 510(k) clearance for the FASTRAY LC. 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 July 26, 1999 after a review of 76 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 - K991631

510(k) Number K991631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1999
Decision Date July 26, 1999
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
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 K991631.
TRAY-LINK
K992001 · Silicon-Und Composite Spezialitaten GmbH · Nov 1999
IMPREGUM F
K992895 · Espe Dental AG · Sep 1999
IMPREGUM PENTA
K992897 · Espe Dental AG · Sep 1999
ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)
K991489 · Harry J. Bosworth Co. · Jul 1999
ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)
K991490 · Harry J. Bosworth Co. · Jul 1999
DIMENSION BITE
K991008 · Espe Dental AG · Jun 1999