Cleared Traditional

K980965 - SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL

K980965 is an FDA 510(k) clearance for SPECTRA FORM CHROMATIC ALGINATE IMPRESS..., manufactured by Cavex Holland BV. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K980965 · Cavex Holland BV · Dental device
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May 1998
Decision
46d
Days
Class 2
Risk

K980965 is an FDA 510(k) clearance for the SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Cavex Holland BV (Harmen, NL). The FDA issued a Cleared decision on May 1, 1998 after a review of 46 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 Cavex Holland BV devices

FDA 510(k) Submission Details - K980965

510(k) Number K980965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1998
Decision Date May 01, 1998
Days to Decision 46 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
82d faster than avg
Panel avg: 128d · This submission: 46d
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 341
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K980965.
LONE STAR IMPRESSION SYSTEMS
K980968 · Lone Star Technologies · Jun 1998
NEOCOLLOID, ORTHOPRINT
K981091 · Zhermack S.P.A. · May 1998
HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
K980963 · Foremost Dental Mfg., Inc. · May 1998
KROMATICA COLOR CHANGING ALGINATE
K974894 · Matech, Inc. · Feb 1998
POSITION PENTA, POSITION PENTA QUICK
K974231 · Espe GmbH & Co. Kg. · Jan 1998
HYDROGUM
K974704 · Zhermack S.P.A. · Jan 1998