Cleared Traditional

K990846 - AMORPHOUS DIAMOND COATED DRILL

K990846 is the FDA 510(k) clearance for AMORPHOUS DIAMOND COATED DRILL by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code DZI) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K990846 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
87d
Days
Class 2
Risk

K990846 is an FDA 510(k) clearance for the AMORPHOUS DIAMOND COATED DRILL. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Nobel Biocare Uas, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on June 10, 1999 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nobel Biocare Uas, Inc. devices

Submission Details

510(k) Number K990846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date June 10, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZI Drill, Bone, Powered

All 24
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K990846.
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