Cleared Traditional

K964330 - BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME...

K964330 is an FDA 510(k) clearance for BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME..., manufactured by BioHorizons Implant Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K964330 · BioHorizons Implant Systems, Inc. · Dental device
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Jan 1997
Decision
78d
Days
Class 2
Risk

K964330 is an FDA 510(k) clearance for the BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by BioHorizons Implant Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 78 days - a notably fast clearance cycle.

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: 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 BioHorizons Implant Systems, Inc. devices

FDA 510(k) Submission Details - K964330

510(k) Number K964330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1996
Decision Date January 17, 1997
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 820
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K964330.
STERI-OSS GOLD ATTACHMENT SYSTEM
K963945 · Steri-Oss, Inc. · Feb 1997
SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
K962576 · Calcitek, Inc. · Feb 1997
ROUND DENTAL BUR
K964944 · Steri-Oss, Inc. · Feb 1997
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
K963951 · BioHorizons Implant Systems, Inc. · Dec 1996
STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT
K963224 · Steri-Oss, Inc. · Nov 1996
FIXTURE MOUNT KIT
K963121 · Steri-Oss, Inc. · Nov 1996