OSSEODENT DRILLING SYSTEM— 510(k) K862110

Substantially Equivalent

Otc/America

FDA 510(k) clearance K862110 for OSSEODENT DRILLING SYSTEM, Substantially Equivalent on 1986-08-07. Applicant: Otc/America.

Clearance details

Applicant: Otc/America
Product code: Code KMW
Advisory panel: Dental
Date received: 1986-06-03
Decision date: 1986-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley Hills, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KMW

product code KMW

Injury: 175
Total: 175

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.