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FDA 510(k)

STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT

K-Number: K973433 · 1997-12-05

ApplicantSteri-Oss, Inc.
Decision Date1997-12-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT 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 1997-12-05 under 510(k) number K973433. 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 STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT?

STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1997-12-05. The listed applicant is Steri-Oss, Inc.. The 510(k) number is K973433.

When did STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT receive FDA 510(k) clearance?

STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT received FDA 510(k) clearance on 1997-12-05, under 510(k) number K973433.

Who is the listed applicant for STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT?

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 STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT?

The FDA product code for STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT 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 IMPLANTK973402STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEMK972965STERI-OSS UNTIL IMPLANT CEMENTK970073BIO-ESTHETIC INDIRECT ABUTMENT

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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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