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FDA 510(k)

OSSEOTITE IRRIGATION UNIT

K-Number: K901600 · 1990-06-21

ApplicantCollagen Corp.
Decision Date1990-06-21
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEOTITE IRRIGATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Corp.. It received FDA 510(k) clearance on 1990-06-21 under 510(k) number K901600. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSEOTITE IRRIGATION UNIT?

OSSEOTITE IRRIGATION UNIT is a medical device that received FDA 510(k) clearance on 1990-06-21. The listed applicant is Collagen Corp.. The 510(k) number is K901600.

When did OSSEOTITE IRRIGATION UNIT receive FDA 510(k) clearance?

OSSEOTITE IRRIGATION UNIT received FDA 510(k) clearance on 1990-06-21, under 510(k) number K901600.

Who is the listed applicant for OSSEOTITE IRRIGATION UNIT?

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 OSSEOTITE IRRIGATION UNIT?

The FDA product code for OSSEOTITE IRRIGATION UNIT is EFS.

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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)K900275OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNETK895462OSSEODENT DENTAL ATTACHMENTSK895463OSSEODENT(R) PRECISION DENTAL ATTACHMENTSK894331OSSEODENT SURGICAL KIT

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Related Devices (Code: EFS)

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.

K023232SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLESmartpracticeK001493DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001Air Force, Inc.K983374AGATHA-A-H2010Midian Intl.K964810DERMADAMUltradent Products, Inc.K952234BARRIER ALL FILMCottrell, Ltd.K943182ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOROral-B Laboratories

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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