510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940908Substantially Equivalent

Dunhall/omnii International Rotary Diamond Burs

Dunhall Pharmaceuticals, Inc., Gravette AR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940908 is the FDA 510(k) clearance record for DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS, a class I device, cleared for Dunhall Pharmaceuticals, Inc. on under FDA product code DZP (Instrument, Diamond, Dental). FDA records list one 510(k) clearance for Dunhall Pharmaceuticals, Inc. As of , FDA records show no recalls naming K940908.

Clearance record

Decision date
Received
(186 days to decision)
Product code
DZP Instrument, Diamond, Dental
Regulation
21 CFR 872.4535
Device class
Class I
Review panel
Dental
Applicant
Dunhall Pharmaceuticals, Inc. P.O. Box 100, Gravette AR
510(k) summary
Statement
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