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FDA 510(k)

DENTAL PIK

K-Number: K892861 · 1989-09-15

ApplicantU.S. Dentek Corp.
Decision Date1989-09-15
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL PIK is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Dentek Corp.. It received FDA 510(k) clearance on 1989-09-15 under 510(k) number K892861. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL PIK?

DENTAL PIK is a medical device that received FDA 510(k) clearance on 1989-09-15. The listed applicant is U.S. Dentek Corp.. The 510(k) number is K892861.

When did DENTAL PIK receive FDA 510(k) clearance?

DENTAL PIK received FDA 510(k) clearance on 1989-09-15, under 510(k) number K892861.

Who is the listed applicant for DENTAL PIK?

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

What is the FDA product code for DENTAL PIK?

The FDA product code for DENTAL PIK is EKS.

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 U.S. Dentek 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.

K961574TONGUE SCRAPPERK931360ELECTRIC TOOTH-BRUSHK881046SUPER PIK MASSAGING PICK FOR ORAL HYGIENE

Related Devices (Code: EKS)

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.

K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, Inc.

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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