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FDA 510(k)

TORX MICRO-MOTOR LOW SPEED HANDPIECE

K-Number: K801687 · 1980-08-04

ApplicantPacific Dental Corp.
Decision Date1980-08-04
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TORX MICRO-MOTOR LOW SPEED HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Dental Corp.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801687. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORX MICRO-MOTOR LOW SPEED HANDPIECE?

TORX MICRO-MOTOR LOW SPEED HANDPIECE is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Pacific Dental Corp.. The 510(k) number is K801687.

When did TORX MICRO-MOTOR LOW SPEED HANDPIECE receive FDA 510(k) clearance?

TORX MICRO-MOTOR LOW SPEED HANDPIECE received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801687.

Who is the listed applicant for TORX MICRO-MOTOR LOW SPEED HANDPIECE?

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

What is the FDA product code for TORX MICRO-MOTOR LOW SPEED HANDPIECE?

The FDA product code for TORX MICRO-MOTOR LOW SPEED HANDPIECE is EKX.

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Other records listing Pacific Dental Corp. as applicant

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Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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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