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FDA 510(k)

TAKE 1 BITE

K-Number: K001876 · 2000-07-21

ApplicantSybron Dental Specialties, Inc.
Decision Date2000-07-21
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TAKE 1 BITE 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 2000-07-21 under 510(k) number K001876. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAKE 1 BITE?

TAKE 1 BITE is a medical device that received FDA 510(k) clearance on 2000-07-21. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K001876.

When did TAKE 1 BITE receive FDA 510(k) clearance?

TAKE 1 BITE received FDA 510(k) clearance on 2000-07-21, under 510(k) number K001876.

Who is the listed applicant for TAKE 1 BITE?

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 TAKE 1 BITE?

The FDA product code for TAKE 1 BITE is ELW.

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Related Devices (Code: ELW)

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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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