TERUMO DENTAL NEEDLES— 510(k) K864970

Name: FDA 510(k) clearance K864970
Creator: U.S. Food and Drug Administration
Published: 1987-03-10

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K864970 for TERUMO DENTAL NEEDLES, Substantially Equivalent on 1987-03-10. Applicant: Terumo Medical Corp.. Device class: 1.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code DZM
Device class: Class 1
Regulation: 21 CFR 872.4730
Advisory panel: Dental
Date received: 1986-12-22
Decision date: 1987-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, 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

More clearances from Terumo Medical Corp.

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K111606 — PINNACLE PRECISION ACCESS SYSTEM2011-10-03
K111556 — GLIDECROSS SUPPORT CATHETER2011-07-29
K110540 — TERUMO SUPPORT CATHETER2011-05-13
K102008 — GLIDESHEATH2010-07-21
K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2009-05-29

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.