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FDA 510(k)

PROCEDURE KIT/ROUTINE DENTAL PROCEDURES

K-Number: K905461 · 1991-03-05

ApplicantAngiosystems, Inc.
Decision Date1991-03-05
Product CodeEKS
Advisory CommitteeDE
DecisionUnknown

Device Summary

PROCEDURE KIT/ROUTINE DENTAL PROCEDURES is the device name listed in this FDA 510(k) record. The listed applicant is Angiosystems, Inc.. It received FDA 510(k) clearance on 1991-03-05 under 510(k) number K905461. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PROCEDURE KIT/ROUTINE DENTAL PROCEDURES?

PROCEDURE KIT/ROUTINE DENTAL PROCEDURES is a medical device that received FDA 510(k) clearance on 1991-03-05. The listed applicant is Angiosystems, Inc.. The 510(k) number is K905461.

When did PROCEDURE KIT/ROUTINE DENTAL PROCEDURES receive FDA 510(k) clearance?

PROCEDURE KIT/ROUTINE DENTAL PROCEDURES received FDA 510(k) clearance on 1991-03-05, under 510(k) number K905461.

Who is the listed applicant for PROCEDURE KIT/ROUTINE DENTAL PROCEDURES?

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

What is the FDA product code for PROCEDURE KIT/ROUTINE DENTAL PROCEDURES?

The FDA product code for PROCEDURE KIT/ROUTINE DENTAL PROCEDURES is EKS.

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Other records listing Angiosystems, Inc. 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.

K905464MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLINGK905459SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOMK905466STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPEK905465STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPEK905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYK905462PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES

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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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