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FDA 510(k)

AMORPHOUS DIAMOND COATED DRILL

K-Number: K990846 · 1999-06-10

ApplicantNobel Biocare Uas, Inc.
Decision Date1999-06-10
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMORPHOUS DIAMOND COATED DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Uas, Inc.. It received FDA 510(k) clearance on 1999-06-10 under 510(k) number K990846. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMORPHOUS DIAMOND COATED DRILL?

AMORPHOUS DIAMOND COATED DRILL is a medical device that received FDA 510(k) clearance on 1999-06-10. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K990846.

When did AMORPHOUS DIAMOND COATED DRILL receive FDA 510(k) clearance?

AMORPHOUS DIAMOND COATED DRILL received FDA 510(k) clearance on 1999-06-10, under 510(k) number K990846.

Who is the listed applicant for AMORPHOUS DIAMOND COATED DRILL?

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

What is the FDA product code for AMORPHOUS DIAMOND COATED DRILL?

The FDA product code for AMORPHOUS DIAMOND COATED DRILL is DZI.

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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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