DEMETRON A.2— 510(k) K063116

Substantially Equivalent

Sybron Dental Specialties

FDA 510(k) clearance K063116 for DEMETRON A.2, Substantially Equivalent on 2006-12-05. Applicant: Sybron Dental Specialties. Device class: 2.

Clearance details

Applicant: Sybron Dental Specialties
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2006-10-12
Decision date: 2006-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBZ

K253131 — Curing Light (M-Cure 6)2026-06-18
K253461 — Demi Pro2025-10-14
K242386 — Bluemoon2025-05-05
K243921 — LED Curing Lights (DB686 HALO)2025-04-11
K250009 — LED Curing Light (C01-X, C02-X)2025-04-10

More clearances from Sybron Dental Specialties

K182826 — Ormco Spark Aligner System2018-10-11
K162063 — Steri-Cassette and Steri-Cage Sterilization Packaging System2017-04-21
K160097 — Image Fast Set, Image Regular Set2016-08-05
K153067 — Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress2016-07-27
K152956 — Pulp Canal Sealer, Pulp Canal Sealer EWT2016-05-06

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