PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.— 510(k) K982480

Name: FDA 510(k) clearance K982480
Creator: U.S. Food and Drug Administration
Published: 1998-09-15

Substantially Equivalent

Dentalview, Inc.

FDA 510(k) clearance K982480 for PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH., Substantially Equivalent on 1998-09-15. Applicant: Dentalview, Inc.. Device class: 1.

Clearance details

Applicant: Dentalview, Inc.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1998-07-16
Decision date: 1998-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K982480

K-number listed on FDA's recall record

Z-2530-2016 — Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).Class II·Terminated·Danville Materials, Inc.·20160624

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982480.

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