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FDA 510(k)

SAF (SELF ADJUSTING FILE)

K-Number: K092933 · 2010-01-14

ApplicantRedent-Nova , Ltd.
Decision Date2010-01-14
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAF (SELF ADJUSTING FILE) is the device name listed in this FDA 510(k) record. The listed applicant is Redent-Nova , Ltd.. It received FDA 510(k) clearance on 2010-01-14 under 510(k) number K092933. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAF (SELF ADJUSTING FILE)?

SAF (SELF ADJUSTING FILE) is a medical device that received FDA 510(k) clearance on 2010-01-14. The listed applicant is Redent-Nova , Ltd.. The 510(k) number is K092933.

When did SAF (SELF ADJUSTING FILE) receive FDA 510(k) clearance?

SAF (SELF ADJUSTING FILE) received FDA 510(k) clearance on 2010-01-14, under 510(k) number K092933.

Who is the listed applicant for SAF (SELF ADJUSTING FILE)?

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

What is the FDA product code for SAF (SELF ADJUSTING FILE)?

The FDA product code for SAF (SELF ADJUSTING FILE) is EFB.

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Related Devices (Code: EFB)

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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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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