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FDA 510(k)

OSSEODENT SURGICAL KIT

K-Number: K894331 · 1989-10-04

ApplicantCollagen Corp.
Decision Date1989-10-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEODENT SURGICAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Corp.. It received FDA 510(k) clearance on 1989-10-04 under 510(k) number K894331. 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 OSSEODENT SURGICAL KIT?

OSSEODENT SURGICAL KIT is a medical device that received FDA 510(k) clearance on 1989-10-04. The listed applicant is Collagen Corp.. The 510(k) number is K894331.

When did OSSEODENT SURGICAL KIT receive FDA 510(k) clearance?

OSSEODENT SURGICAL KIT received FDA 510(k) clearance on 1989-10-04, under 510(k) number K894331.

Who is the listed applicant for OSSEODENT SURGICAL KIT?

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

What is the FDA product code for OSSEODENT SURGICAL KIT?

The FDA product code for OSSEODENT SURGICAL KIT is DZE.

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Other records listing Collagen 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.

K904671QAR HANDPIECEK904228OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)K901600OSSEOTITE IRRIGATION UNITK900275OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNETK895462OSSEODENT DENTAL ATTACHMENTSK895463OSSEODENT(R) PRECISION DENTAL ATTACHMENTS

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Related Devices (Code: DZE)

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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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