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FDA 510(k)

STERI-OSS

K-Number: K884845 · 1989-02-10

ApplicantDenar Corp.
Decision Date1989-02-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERI-OSS is the device name listed in this FDA 510(k) record. The listed applicant is Denar Corp.. It received FDA 510(k) clearance on 1989-02-10 under 510(k) number K884845. 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?

STERI-OSS is a medical device that received FDA 510(k) clearance on 1989-02-10. The listed applicant is Denar Corp.. The 510(k) number is K884845.

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

STERI-OSS received FDA 510(k) clearance on 1989-02-10, under 510(k) number K884845.

Who is the listed applicant for STERI-OSS?

The FDA 510(k) record lists Denar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERI-OSS?

The FDA product code for STERI-OSS is DZE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Denar Corp. 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.

K925705ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEMK924759COLLIMATOR LIGHT SOURCEK883373STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANTK852802DENAR DENTAL IMPLANT

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

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

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