Cleared Traditional

K922559 - ACUFEX ENDOFIX BUTTON

K922559 is an FDA 510(k) clearance for ACUFEX ENDOFIX BUTTON, manufactured by Acufex Microsurgical, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K922559 · Acufex Microsurgical, Inc. · Dental device
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Dec 1992
Decision
209d
Days
Class 2
Risk

K922559 is an FDA 510(k) clearance for the ACUFEX ENDOFIX BUTTON. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on December 24, 1992 after a review of 209 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K922559

510(k) Number K922559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1992
Decision Date December 24, 1992
Days to Decision 209 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 slower than avg
Panel avg: 127d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 150
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K922559.
DENTALON PLUS MODIFICATION
K934283 · Heraeus Kulzer, Inc. · Dec 1993
FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL
K934978 · Ivoclar North America, Inc. · Dec 1993
PALAVIT 55 AND DENTACOLOR CONNECTOR
K932034 · Heraeus Kulzer, Inc. · Aug 1993
SEPTOPACK TEMPORARY FILLING
K915466 · Specialites Septodont · Feb 1992
DENTALON PLUS
K903317 · Kulzer, Inc. · Aug 1990
PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)
K901077 · Scientific Pharmaceuticals, Inc. · May 1990