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FDA 510(k)

BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)

K-Number: K964330 · 1997-01-17

ApplicantBioHorizons Implant Systems, Inc.
Decision Date1997-01-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 1997-01-17 under 510(k) number K964330. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)?

BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K964330.

When did BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) receive FDA 510(k) clearance?

BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) received FDA 510(k) clearance on 1997-01-17, under 510(k) number K964330.

Who is the listed applicant for BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)?

The FDA 510(k) record lists BioHorizons Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)?

The FDA product code for BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) is DZE.

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Other records listing BioHorizons Implant Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260061BioHorizons CEREC Compatible Ti-BasesK243521Conical Ti Base abutmentsK240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentK240187Tapered Pro Conical Implant SystemK223697MRI compatibility for existing BioHorizons dental implants and abutmentsK203252Multi-unit Abutments for CONELOG

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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