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FDA 510(k)

STERI-OSS UNTIL IMPLANT CEMENT

K-Number: K972965 · 1997-11-07

ApplicantSteri-Oss, Inc.
Decision Date1997-11-07
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERI-OSS UNTIL IMPLANT CEMENT 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 1997-11-07 under 510(k) number K972965. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERI-OSS UNTIL IMPLANT CEMENT?

STERI-OSS UNTIL IMPLANT CEMENT is a medical device that received FDA 510(k) clearance on 1997-11-07. The listed applicant is Steri-Oss, Inc.. The 510(k) number is K972965.

When did STERI-OSS UNTIL IMPLANT CEMENT receive FDA 510(k) clearance?

STERI-OSS UNTIL IMPLANT CEMENT received FDA 510(k) clearance on 1997-11-07, under 510(k) number K972965.

Who is the listed applicant for STERI-OSS UNTIL IMPLANT CEMENT?

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 UNTIL IMPLANT CEMENT?

The FDA product code for STERI-OSS UNTIL IMPLANT CEMENT is EMA.

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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 SYSTEMK970073BIO-ESTHETIC INDIRECT ABUTMENT

View all 46 devices →

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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