Cleared Special

K053152 - BIOHORIZONS SINGLE-STAGE IMPLANT

K053152 is an FDA 510(k) clearance for BIOHORIZONS SINGLE-STAGE IMPLANT, manufactured by BioHorizons Implant Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 22-day FDA review.

K053152 · BioHorizons Implant Systems, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
22d
Days
Class 2
Risk

K053152 is an FDA 510(k) clearance for the BIOHORIZONS SINGLE-STAGE IMPLANT. 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 December 2, 2005 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K053152

510(k) Number K053152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2005
Decision Date December 02, 2005
Days to Decision 22 days
Submission Type Special
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
106d faster than avg
Panel avg: 128d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 1546
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K053152.
HDC SPIDER SCREW
K052471 · Hdc S.R.L. · Dec 2005
ALMITECH INC. DENTAL IMPLANT SYSTEM
K052733 · Almitech, Inc. · Dec 2005
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K052490 · Northern Implants, LLC · Dec 2005
MODUS IMF SCREWS 2.0
K052061 · Medartis, Inc. · Oct 2005
MILO DENTAL IMPLANT SYSTEM
K050970 · Intra-Lock International · Oct 2005
SISTEMA DE IMPLANTE NACIONAL (S.I.N.)
K051859 · Sin Sistema DE Implante Nacional Ltda · Sep 2005
K053152 · BIOHORIZONS SINGLE-STAGE IMPLANT
Download PDF FDA Summary BioHorizons Implant S…