NUANCE— 510(k) K101215

Substantially Equivalent

Discus Dental, LLC

FDA 510(k) clearance K101215 for NUANCE, Substantially Equivalent on 2010-05-12. Applicant: Discus Dental, LLC. Device class: 2.

Clearance details

Applicant: Discus Dental, LLC
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2010-04-30
Decision date: 2010-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Discus Dental, LLC

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