SINGLES— 510(k) K930453

Substantially Equivalent

Nexadental

FDA 510(k) clearance K930453 for SINGLES, Substantially Equivalent on 1993-05-27. Applicant: Nexadental. Device class: 1.

Clearance details

Applicant: Nexadental
Product code: Code ECI
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1993-01-27
Decision date: 1993-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Omaha, NE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ECI

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K980053 — GLENROE CHAIN1998-02-24
K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURES1997-12-01
K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE1995-05-24
K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD1995-05-23

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