510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031793Substantially Equivalent

Dentatus Osciomat

Dentatus USA Ltd., Sound Beach NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031793 is the FDA 510(k) clearance record for DENTATUS OSCIOMAT, a class II device, cleared for Dentatus USA , Ltd. on under FDA product code DZH (Saw, Bone, Ac-Powered). FDA records list 4 510(k) clearances for Dentatus USA , Ltd., from to . As of , FDA records show no recalls naming K031793.

Clearance record

Decision date
Received
(156 days to decision)
Product code
DZH Saw, Bone, Ac-Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Dentatus USA , Ltd. 30 Northport Rd., Sound Beach NY
510(k) summary
Statement
Third party review
No

Clearances, product code DZH

Trailing 12 months

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

FDA records show no clearances under product code DZH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DZH, 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