Cleared Traditional

K991490 - ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)

K991490 is an FDA 510(k) clearance for ALGINATE IMPRESSION MATERIAL II (FAST &..., 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 78-day FDA review.

K991490 · Harry J. Bosworth Co. · Dental device
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Jul 1999
Decision
78d
Days
Class 2
Risk

K991490 is an FDA 510(k) clearance for the ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET). 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 15, 1999 after a review of 78 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 - K991490

510(k) Number K991490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date July 15, 1999
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 K991490.
IMPREGUM PENTA
K992897 · Espe Dental AG · Sep 1999
FASTRAY LC
K991631 · Harry J. Bosworth Co. · Jul 1999
ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)
K991489 · Harry J. Bosworth Co. · Jul 1999
DIMENSION BITE
K991008 · Espe Dental AG · Jun 1999
XANTOPREN COMFORT
K991425 · Heraeus Kulzer, Inc. · Jun 1999
VESTOGUM
K991221 · Espe Dental AG · May 1999