DENTAL NEEDLE PROTECTIVE SYSTEM— 510(k) K910475

Name: FDA 510(k) clearance K910475
Creator: U.S. Food and Drug Administration
Published: 1991-09-13

Substantially Equivalent

Health Technology Systems, Inc.

FDA 510(k) clearance K910475 for DENTAL NEEDLE PROTECTIVE SYSTEM, Substantially Equivalent on 1991-09-13. Applicant: Health Technology Systems, Inc.. Device class: 1.

Clearance details

Applicant: Health Technology Systems, Inc.
Product code: Code DZM
Device class: Class 1
Regulation: 21 CFR 872.4730
Advisory panel: Dental
Date received: 1991-02-06
Decision date: 1991-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, KY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZM

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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
K910446 — STABIDENT LOCAL ANESTHESIA SYSTEM1991-06-03

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.