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FDA 510(k)

REPLACE TITANIUM IMPLANT SYSTEM

K-Number: K964220 · 1997-03-05

ApplicantSteri-Oss, Inc.
Decision Date1997-03-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPLACE TITANIUM IMPLANT SYSTEM 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 1997-03-05 under 510(k) number K964220. 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 REPLACE TITANIUM IMPLANT SYSTEM?

REPLACE TITANIUM IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-05. The listed applicant is Steri-Oss, Inc.. The 510(k) number is K964220.

When did REPLACE TITANIUM IMPLANT SYSTEM receive FDA 510(k) clearance?

REPLACE TITANIUM IMPLANT SYSTEM received FDA 510(k) clearance on 1997-03-05, under 510(k) number K964220.

Who is the listed applicant for REPLACE TITANIUM IMPLANT SYSTEM?

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 REPLACE TITANIUM IMPLANT SYSTEM?

The FDA product code for REPLACE TITANIUM IMPLANT SYSTEM is DZE.

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Other records listing Steri-Oss, 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.

K982400STERI-OSS' IMPROV TEMPORARY DENTAL CEMENTK980439REPLACE CYLINDRICAL IMPLANTSK973423STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANTK973433STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANTK973402STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEMK972965STERI-OSS UNTIL IMPLANT CEMENT

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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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