510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990846Substantially Equivalent

Amorphous Diamond Coated Drill

Nobel Biocare Uas, Inc., Yorba Linda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990846 is the FDA 510(k) clearance record for AMORPHOUS DIAMOND COATED DRILL, a class II device, cleared for Nobel Biocare Uas, Inc. on under FDA product code DZI (Drill, Bone, Powered). FDA records list 31 510(k) clearances for Nobel Biocare Uas, Inc., from to . As of , FDA records show 15 recalls naming K990846.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DZI Drill, Bone, Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Nobel Biocare Uas, Inc. 22895 Eastpark Dr., Yorba Linda CA
510(k) summary
Summary
Third party review
No

Clearances, product code DZI

Trailing 12 months
3 clearances under product code DZI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260