Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PERIOGARD(R) PERIOPEN

K-Number: K901955 · 1991-04-15

ApplicantColgate-Palmolive Co.
Decision Date1991-04-15
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERIOGARD(R) PERIOPEN is the device name listed in this FDA 510(k) record. The listed applicant is Colgate-Palmolive Co.. It received FDA 510(k) clearance on 1991-04-15 under 510(k) number K901955. 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 PERIOGARD(R) PERIOPEN?

PERIOGARD(R) PERIOPEN is a medical device that received FDA 510(k) clearance on 1991-04-15. The listed applicant is Colgate-Palmolive Co.. The 510(k) number is K901955.

When did PERIOGARD(R) PERIOPEN receive FDA 510(k) clearance?

PERIOGARD(R) PERIOPEN received FDA 510(k) clearance on 1991-04-15, under 510(k) number K901955.

Who is the listed applicant for PERIOGARD(R) PERIOPEN?

The FDA 510(k) record lists Colgate-Palmolive Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERIOGARD(R) PERIOPEN?

The FDA product code for PERIOGARD(R) PERIOPEN is EFS.

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 Colgate-Palmolive Co. 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.

K103461COLGATE DESENSITIZING DENTAL CREAMK944886COLGATE PRECISION MINT WZXED DENTAL FLOSSK883335COLGATE DENTAL FLOSS

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.

↑