Cleared Traditional

K926305 - IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER

K926305 is an FDA 510(k) clearance for IMPLA-MED HEX SCREW IMPLANTS: 4, manufactured by The Stern Metals Co., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K926305 · The Stern Metals Co., Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
441d
Days
Class 2
Risk

K926305 is an FDA 510(k) clearance for the IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by The Stern Metals Co., Inc. (Attleboro, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K926305

510(k) Number K926305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1992
Decision Date March 01, 1994
Days to Decision 441 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 128d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1538
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K926305.
STRYKER PRECISION DENTAL IMPLANT SYSTEM
K921805 · Stryker Instruments · Mar 1994
IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L
K933193 · The Stern Metals Co., Inc. · Mar 1994
CONICAL ABUTMENT
K933462 · Implant Innovations, Inc. · Mar 1994
ENDOSSEOUS IMPLANTS
K924219 · The Stern Metals Co., Inc. · Feb 1994
MINIBALL ABUTMENT
K930155 · Steri-Oss, Inc. · Feb 1994
INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER
K922732 · Interpore Intl. · Feb 1994
K926305 · IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER
Download PDF FDA Summary The Stern Metals Co.,…