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FDA 510(k)

STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT

K-Number: K883373 · 1989-01-13

ApplicantDenar Corp.
Decision Date1989-01-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Denar Corp.. It received FDA 510(k) clearance on 1989-01-13 under 510(k) number K883373. 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 HYDROXYAPATITE-COATED DENTAL IMPLANT?

STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1989-01-13. The listed applicant is Denar Corp.. The 510(k) number is K883373.

When did STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT receive FDA 510(k) clearance?

STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT received FDA 510(k) clearance on 1989-01-13, under 510(k) number K883373.

Who is the listed applicant for STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT?

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 HYDROXYAPATITE-COATED DENTAL IMPLANT?

The FDA product code for STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT 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.

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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 SOURCEK884845STERI-OSSK852802DENAR 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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