510(k) Report

510(k) · Cleared

Cleared

Nipro Dental Needle

K894373510(k) TraditionalCleared Oct 13, 198988-day reviewClass I21 CFR 872.4730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pharma-Plast USA, Inc. · DZM Needle, Dental

Cleared on Oct 13, 1989 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 13, 1989
Review
88 days
Class
Class I
Product code
DZM
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K894373Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DZM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DZM devices

DZM Needle, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZM

FDA has decided no DZM device since 2007.

Median 510(k) review, days · DZM

Too few DZM 510(k)s in any year since 2007 to give a median.

Recalls per year · DZM

No recall names DZM since 2007.

Adverse event reports per year · DZM

11in 2025

2007: 142008: 232009: 1032010: 192011: 112012: 172013: 182014: 102015: 102016: 372017: 252018: 382019: 312020: 162021: 412022: 352023: 342024: 272025: 11
2007high 103 (2009) · low 10 (2014)2025

MAUDE reports naming product code DZM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—014
20080—023
20090—0103
20100—019
20110—011
20120—017
20130—018
20140—010
20150—010
20160—037
20170—025
20180—038
20190—031
20200—016
20210—041
20220—035
20230—034
20240—027
20250—011
20260—0—

More from Pharma-Plast USA, Inc.

9 FDA decisions under this applicant name. See the company

  • K894371Nipro Safelet CathPharma-Plast USA, Inc. · 1989
  • K894374Blood Drawing NeedlePharma-Plast USA, Inc. · 1989
  • K894372Nipro Needle HolderPharma-Plast USA, Inc. · 1989
  • K884978Pharma-Plast Insulin Infusion SetPharma-Plast USA, Inc. · 1989
  • K871263Multiple Pharma-Plast Tracheal TubePharma-Plast USA, Inc. · 1987

Recent decisions in DZM

The DZM category page

  • K990511X-Tip Intraosseous PerforatorSchiff & Co. · 1999
  • K920758Jenker Needle Stick ProtectorDentsply Intl. · 1992
  • K914562Aseptic Dental Tech. Total Treatment SystemAseptic Dental Technologies, Inc. · 1992
  • K913573Safety Plus Dental Injection NeedleSpecialites Septodont · 1991
  • K910475Dental Needle Protective SystemHealth Technology Systems, Inc. · 1991

https://510kreport.com/device/K894373 · printed Nov 4, 2026

Cite this page

510(k) Report. “K894373: Nipro Dental Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894373

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026