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FDA 510(k)

BONE CUTTING INSTRUMENT AND ACCESSORIES

K-Number: K950446 · 1995-05-03

ApplicantSteri-Oss, Inc.
Decision Date1995-05-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONE CUTTING INSTRUMENT AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Steri-Oss, Inc.. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K950446. 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 BONE CUTTING INSTRUMENT AND ACCESSORIES?

BONE CUTTING INSTRUMENT AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Steri-Oss, Inc.. The 510(k) number is K950446.

When did BONE CUTTING INSTRUMENT AND ACCESSORIES receive FDA 510(k) clearance?

BONE CUTTING INSTRUMENT AND ACCESSORIES received FDA 510(k) clearance on 1995-05-03, under 510(k) number K950446.

Who is the listed applicant for BONE CUTTING INSTRUMENT AND ACCESSORIES?

The FDA 510(k) record lists Steri-Oss, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONE CUTTING INSTRUMENT AND ACCESSORIES?

The FDA product code for BONE CUTTING INSTRUMENT AND ACCESSORIES is DZE.

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Other records listing Steri-Oss, Inc. as applicant

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Related Devices (Code: DZE)

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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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