REGENCY TUBE— 510(k) K936243

Substantially Equivalent

Ortho Specialties

FDA 510(k) clearance K936243 for REGENCY TUBE, Substantially Equivalent on 1994-02-02. Applicant: Ortho Specialties. Device class: 1.

Clearance details

Applicant: Ortho Specialties
Product code: Code DZD
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1993-12-30
Decision date: 1994-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hickory Hills, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZD

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K935143 — DENTAURUM STAINLESS STEEL TUBING1994-01-31
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K896586 — RATE INCREASE FOR IPPB/IPV1990-01-09
K834446 — ALEXOTEK LINGUAL TUBES1984-04-05

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Data sourced from openFDA. This site is unofficial and independent of the FDA.