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FDA 510(k)

DENAR DENTAL IMPLANT

K-Number: K852802 · 1985-09-23

ApplicantDenar Corp.
Decision Date1985-09-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENAR 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 1985-09-23 under 510(k) number K852802. 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 DENAR DENTAL IMPLANT?

DENAR DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1985-09-23. The listed applicant is Denar Corp.. The 510(k) number is K852802.

When did DENAR DENTAL IMPLANT receive FDA 510(k) clearance?

DENAR DENTAL IMPLANT received FDA 510(k) clearance on 1985-09-23, under 510(k) number K852802.

Who is the listed applicant for DENAR 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 DENAR DENTAL IMPLANT?

The FDA product code for DENAR 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-OSSK883373STERI-OSS HYDROXYAPATITE-COATED 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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