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FDA 510(k)

B&R DEVICE

K-Number: K032925 · 2003-12-22

ApplicantRonvig A/S
Decision Date2003-12-22
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

B&R DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ronvig A/S. It received FDA 510(k) clearance on 2003-12-22 under 510(k) number K032925. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B&R DEVICE?

B&R DEVICE is a medical device that received FDA 510(k) clearance on 2003-12-22. The listed applicant is Ronvig A/S. The 510(k) number is K032925.

When did B&R DEVICE receive FDA 510(k) clearance?

B&R DEVICE received FDA 510(k) clearance on 2003-12-22, under 510(k) number K032925.

Who is the listed applicant for B&R DEVICE?

The FDA 510(k) record lists Ronvig A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B&R DEVICE?

The FDA product code for B&R DEVICE is EGS.

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 Ronvig A/S 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.

K010816DENTO-PREP PARTICLE MICROBLASTER

Related Devices (Code: EGS)

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.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) LimitedK240950Disposable Prophy AnglePacific Care LimitedK240183Star E900 Handpiece SeriesDentalez, Inc., Stardental DivisionK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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