NIPRO DENTAL NEEDLE— 510(k) K894373

Name: FDA 510(k) clearance K894373
Creator: U.S. Food and Drug Administration
Published: 1989-10-13

Substantially Equivalent

Pharma-Plast USA, Inc.

FDA 510(k) clearance K894373 for NIPRO DENTAL NEEDLE, Substantially Equivalent on 1989-10-13. Applicant: Pharma-Plast USA, Inc.. Device class: 1.

Clearance details

Applicant: Pharma-Plast USA, Inc.
Product code: Code DZM
Device class: Class 1
Regulation: 21 CFR 872.4730
Advisory panel: Dental
Date received: 1989-07-17
Decision date: 1989-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Pharma-Plast USA, Inc.

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K894371 — NIPRO SAFELET CATH1989-10-25
K894372 — NIPRO NEEDLE HOLDER1989-09-28
K894374 — BLOOD DRAWING NEEDLE1989-09-28
K884978 — PHARMA-PLAST INSULIN INFUSION SET1989-06-21
K871263 — MULTIPLE PHARMA-PLAST TRACHEAL TUBE1987-06-15

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.