STABIDENT LOCAL ANESTHESIA SYSTEM— 510(k) K910446

Name: FDA 510(k) clearance K910446
Creator: U.S. Food and Drug Administration
Published: 1991-06-03

Substantially Equivalent

Fairfax Dental, Inc.

FDA 510(k) clearance K910446 for STABIDENT LOCAL ANESTHESIA SYSTEM, Substantially Equivalent on 1991-06-03. Applicant: Fairfax Dental, Inc.. Device class: 1.

Clearance details

Applicant: Fairfax Dental, Inc.
Product code: Code DZM
Device class: Class 1
Regulation: 21 CFR 872.4730
Advisory panel: Dental
Date received: 1991-01-14
Decision date: 1991-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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K990511 — X-TIP INTRAOSSEOUS PERFORATOR1999-04-27
K920758 — JENKER NEEDLE STICK PROTECTOR1992-04-28
K914562 — ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM1992-03-09
K913573 — SAFETY PLUS DENTAL INJECTION NEEDLE1991-11-07
K910475 — DENTAL NEEDLE PROTECTIVE SYSTEM1991-09-13

Adverse events under product code DZM

product code DZM

Injury: 139
Total: 139

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.