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FDA 510(k)

BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P

K-Number: K101064 · 2010-09-14

ApplicantBredent GmbH & Co. KG
Decision Date2010-09-14
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P is the device name listed in this FDA 510(k) record. The listed applicant is Bredent GmbH & Co. KG. It received FDA 510(k) clearance on 2010-09-14 under 510(k) number K101064. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P?

BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P is a medical device that received FDA 510(k) clearance on 2010-09-14. The listed applicant is Bredent GmbH & Co. KG. The 510(k) number is K101064.

When did BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P receive FDA 510(k) clearance?

BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P received FDA 510(k) clearance on 2010-09-14, under 510(k) number K101064.

Who is the listed applicant for BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P?

The FDA 510(k) record lists Bredent GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P?

The FDA product code for BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P is ELM.

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Other records listing Bredent GmbH & Co. KG as applicant

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Related Devices (Code: ELM)

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Official Source

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