510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901262Substantially Equivalent

F.g. Laser (Dental Bur)

Diamond Rotary and Carbide Intl., Canada R3c 4e5, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901262 is the FDA 510(k) clearance record for F.G. LASER (DENTAL BUR), a class I device, cleared for Diamond Rotary and Carbide Intl. on under FDA product code DZP (Instrument, Diamond, Dental). FDA records list one 510(k) clearance for Diamond Rotary and Carbide Intl. As of , FDA records show no recalls naming K901262.

Clearance record

Decision date
Received
(115 days to decision)
Product code
DZP Instrument, Diamond, Dental
Regulation
21 CFR 872.4535
Device class
Class I
Review panel
Dental
Applicant
Diamond Rotary and Carbide Intl. P.O. Box 3092, Canada R3c 4e5, 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