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FDA 510(k)

DENTATUS OSCIOMAT

K-Number: K031793 · 2003-11-13

ApplicantDentatus USA , Ltd.
Decision Date2003-11-13
Product CodeDZH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTATUS OSCIOMAT is the device name listed in this FDA 510(k) record. The listed applicant is Dentatus USA , Ltd.. It received FDA 510(k) clearance on 2003-11-13 under 510(k) number K031793. The device is classified under product code DZH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTATUS OSCIOMAT?

DENTATUS OSCIOMAT is a medical device that received FDA 510(k) clearance on 2003-11-13. The listed applicant is Dentatus USA , Ltd.. The 510(k) number is K031793.

When did DENTATUS OSCIOMAT receive FDA 510(k) clearance?

DENTATUS OSCIOMAT received FDA 510(k) clearance on 2003-11-13, under 510(k) number K031793.

Who is the listed applicant for DENTATUS OSCIOMAT?

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

What is the FDA product code for DENTATUS OSCIOMAT?

The FDA product code for DENTATUS OSCIOMAT is DZH.

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.

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Other records listing Dentatus USA , Ltd. 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.

K042931TUF LINK SILICONE RELINERK980620DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEMK961704MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM

Related Devices (Code: DZH)

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.

K935443ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMSOsada Electric Co., Ltd.K760958SURGICAL OSCILLATING SAWAmerican Safety Equipment Corp.K760957SURGICAL RECIPROCATING SAWAmerican Safety Equipment Corp.

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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