Cleared Traditional

K830044 - ODONTIC CENTRIC(BITE) REGIST. PASTE

K830044 is the FDA 510(k) clearance for ODONTIC CENTRIC(BITE) REGIST. PASTE by Wallace A. Erickson & Co.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K830044 · Wallace A. Erickson & Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
89d
Days
Class 2
Risk

K830044 is an FDA 510(k) clearance for the ODONTIC CENTRIC(BITE) REGIST. PASTE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Wallace A. Erickson & Co. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983 after a review of 89 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 Wallace A. Erickson & Co. devices

Submission Details

510(k) Number K830044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1983
Decision Date April 06, 1983
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 156
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K830044.
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ALGINATE IMPRESSION MATERIAL
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ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587 · Dentsply Intl. · Jul 1980