Cleared Traditional

FRIOS BONESHIELD (K973924) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973924 · Friatec AG · Dental device
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May 1998
Decision
204d
Days
Class 2
Risk

K973924 is an FDA 510(k) clearance for the FRIOS BONESHIELD. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Friatec AG (Potomac, US). The FDA issued a Cleared decision on May 7, 1998 after a review of 204 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Friatec AG devices

Submission Details

510(k) Number K973924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1997
Decision Date May 07, 1998
Days to Decision 204 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
77d slower than avg
Panel avg: 127d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 93
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K973924.
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES
K981890 · Synthes (Usa) · Aug 1998
LACTOSORB PANELS AND FASTENERS
K980927 · Biomet, Inc. · Jun 1998
20-HOLE ADAPTATION PLATE
K981070 · Biomet, Inc. · May 1998
SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)
K974555 · Synthes (Usa) · Mar 1998
SYNTHES RESORBABLE FIXATION SYSTEM
K974554 · Synthes (Usa) · Feb 1998
SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
K971987 · Synthes (Usa) · Jun 1997