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FDA 510(k)

BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2

K-Number: K013009 · 2001-10-03

ApplicantSybron Dental Specialties, Inc.
Decision Date2001-10-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 2001-10-03 under 510(k) number K013009. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2?

BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 is a medical device that received FDA 510(k) clearance on 2001-10-03. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K013009.

When did BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 receive FDA 510(k) clearance?

BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 received FDA 510(k) clearance on 2001-10-03, under 510(k) number K013009.

Who is the listed applicant for BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2?

The FDA 510(k) record lists Sybron Dental Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2?

The FDA product code for BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 is EBF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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