Cleared Traditional

K942521 - CONSERVA POST SYSTEM

K942521 is an FDA 510(k) clearance for CONSERVA POST SYSTEM, manufactured by Bull Frog Mfg. Co.. The device is a Class 1 Dental device with product code ELR cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K942521 · Bull Frog Mfg. Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
43d
Days
Class 1
Risk

K942521 is an FDA 510(k) clearance for the CONSERVA POST SYSTEM. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Bull Frog Mfg. Co. (Portland, US). The FDA issued a Cleared decision on July 8, 1994 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3810 - 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 Bull Frog Mfg. Co. devices

FDA 510(k) Submission Details - K942521

510(k) Number K942521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1994
Decision Date July 08, 1994
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

ELR Device Classification - Class 1, General Controls

Product Code ELR Post, Root Canal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ELR Post, Root Canal

All 21
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K942521.
COSMOPOST
K972875 · Ivoclar North America, Inc. · Sep 1997
C-POST
K945370 · Bisco, Inc. · Mar 1995
THE STERN ROOT ANCHOR SYSTEM
K950213 · Sterngold/Implamed · Mar 1995
PARAPOST XT SYSTEM
K934192 · Coltene/Whaledent, Inc. · Jun 1994
ENDO-CORE
K912720 · Metalor Dental USA Corp. · Aug 1991
FILPOST
K896928 · Ivoclar North America, Inc. · Mar 1990