510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K923757Substantially Equivalent

Dental Diamond Drills

Alpha Industrializacao de Metais Ltda., Taboso De Serra Brazil, BR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923757 is the FDA 510(k) clearance record for DENTAL DIAMOND DRILLS, a class I device, cleared for Alpha Industrializacao DE Metais Ltda. on under FDA product code DZP (Instrument, Diamond, Dental). FDA records list one 510(k) clearance for Alpha Industrializacao DE Metais Ltda. As of , FDA records show no recalls naming K923757.

Clearance record

Decision date
Received
(231 days to decision)
Product code
DZP Instrument, Diamond, Dental
Regulation
21 CFR 872.4535
Device class
Class I
Review panel
Dental
Applicant
Alpha Industrializacao DE Metais Ltda. Rua Aurea Tavares, Taboso De Serra Brazil, BR
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