510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901967Substantially Equivalent

Dendia Werk Burs and Cutting Discs

Micro-Aire Surgical Instruments, Inc., Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901967 is the FDA 510(k) clearance record for DENDIA WERK BURS AND CUTTING DISCS, a class I device, cleared for Micro-Aire Surgical Instruments, Inc. on under FDA product code DZP (Instrument, Diamond, Dental). FDA records list 40 510(k) clearances for Micro-Aire Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K901967.

Clearance record

Decision date
Received
(73 days to decision)
Product code
DZP Instrument, Diamond, Dental
Regulation
21 CFR 872.4535
Device class
Class I
Review panel
Dental
Applicant
Micro-Aire Surgical Instruments, Inc. 24971 Ave. Stanford W., Valencia CA
Third party review
No

Clearances, product code DZP

Trailing 12 months

FDA records hold no clearances under product code DZP in the trailing twelve months.

FDA records show no clearances under product code DZP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DZP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260