510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862110Substantially Equivalent

Osseodent Drilling System

Otc/America, Wellesley Hills MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862110 is the FDA 510(k) clearance record for OSSEODENT DRILLING SYSTEM, a class II device, cleared for Otc/America on under FDA product code KMW (Handpiece, Rotary Bone Cutting). FDA records list 2 510(k) clearances for Otc/America, from to . As of , FDA records show no recalls naming K862110.

Clearance record

Decision date
Received
(65 days to decision)
Product code
KMW Handpiece, Rotary Bone Cutting
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Otc/America 37 Walnut St., Wellesley Hills MA
Third party review
No

Clearances, product code KMW

Trailing 12 months

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

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