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FDA 510(k)

3M UNITEK LAVA CHAIRSIDE ORAL SCANNER

K-Number: K081961 · 2008-09-05

ApplicantBrontes Technologies
Decision Date2008-09-05
Product CodeNOF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M UNITEK LAVA CHAIRSIDE ORAL SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Brontes Technologies. It received FDA 510(k) clearance on 2008-09-05 under 510(k) number K081961. The device is classified under product code NOF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER?

3M UNITEK LAVA CHAIRSIDE ORAL SCANNER is a medical device that received FDA 510(k) clearance on 2008-09-05. The listed applicant is Brontes Technologies. The 510(k) number is K081961.

When did 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER receive FDA 510(k) clearance?

3M UNITEK LAVA CHAIRSIDE ORAL SCANNER received FDA 510(k) clearance on 2008-09-05, under 510(k) number K081961.

Who is the listed applicant for 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER?

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

What is the FDA product code for 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER?

The FDA product code for 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER is NOF.

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 Brontes Technologies 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.

K0731993M ESPE LAVA CHAIRSIDE ORAL SCANNER

Related Devices (Code: NOF)

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.

K122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USEOrmco Corp.K1224673M TRUE DEFINITION SCANNER3M CompanyK0731993M ESPE LAVA CHAIRSIDE ORAL SCANNERBrontes Technologies

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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