Cleared Traditional

K973056 - BONE GRAFT SCREW SYSTEM

K973056 is an FDA 510(k) clearance for BONE GRAFT SCREW SYSTEM, manufactured by Bicon, Inc.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K973056 · Bicon, Inc. · Dental device
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Nov 1997
Decision
89d
Days
Class 2
Risk

K973056 is an FDA 510(k) clearance for the BONE GRAFT SCREW SYSTEM. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Bicon, Inc. (Boston, US). The FDA issued a Cleared decision on November 12, 1997 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 Bicon, Inc. devices

FDA 510(k) Submission Details - K973056

510(k) Number K973056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1997
Decision Date November 12, 1997
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 62
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K973056.
LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM
K974392 · Biovision GmbH · Jan 1998
3I BIORESORBABLE FIXATION TACK
K972480 · Implant Innovations, Inc. · Dec 1997
IMTEC BONE TAC
K973180 · Imtec Corp. · Nov 1997
OSTEOMED QUICKFIX
K962774 · Osteomed Corp. · Oct 1997
SMF TITANIUM (TI) ALLOY BONE SCREWS
K963546 · Synthes (Usa) · Jun 1997
SMF STAINLESS STEEL BONE SCREWS
K964261 · Synthes (Usa) · Apr 1997