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FDA 510(k)

ENCORE BOND

K-Number: K971121 · 1997-06-27

ApplicantCentrix, Inc.
Decision Date1997-06-27
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENCORE BOND is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971121. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCORE BOND?

ENCORE BOND is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Centrix, Inc.. The 510(k) number is K971121.

When did ENCORE BOND receive FDA 510(k) clearance?

ENCORE BOND received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971121.

Who is the listed applicant for ENCORE BOND?

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

What is the FDA product code for ENCORE BOND?

The FDA product code for ENCORE BOND is KLE.

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Other records listing Centrix, Inc. as applicant

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Related Devices (Code: KLE)

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

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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