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FDA 510(k)

PULP CANAL SEALER EWT

K-Number: K945244 · 1994-12-29

ApplicantSybron Dental Specialties, Inc.
Decision Date1994-12-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULP CANAL SEALER EWT 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 1994-12-29 under 510(k) number K945244. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULP CANAL SEALER EWT?

PULP CANAL SEALER EWT is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K945244.

When did PULP CANAL SEALER EWT receive FDA 510(k) clearance?

PULP CANAL SEALER EWT received FDA 510(k) clearance on 1994-12-29, under 510(k) number K945244.

Who is the listed applicant for PULP CANAL SEALER EWT?

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 PULP CANAL SEALER EWT?

The FDA product code for PULP CANAL SEALER EWT is EMA.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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