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FDA 510(k)

BONDING BASE

K-Number: K973353 · 1997-12-02

ApplicantStraumann USA
Decision Date1997-12-02
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONDING BASE is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 1997-12-02 under 510(k) number K973353. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONDING BASE?

BONDING BASE is a medical device that received FDA 510(k) clearance on 1997-12-02. The listed applicant is Straumann USA. The 510(k) number is K973353.

When did BONDING BASE receive FDA 510(k) clearance?

BONDING BASE received FDA 510(k) clearance on 1997-12-02, under 510(k) number K973353.

Who is the listed applicant for BONDING BASE?

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

What is the FDA product code for BONDING BASE?

The FDA product code for BONDING BASE is DZE.

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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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