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FDA 510(k)

TRY-IN GEL

K-Number: K954643 · 1995-10-19

ApplicantSybron Dental Specialties, Inc.
Decision Date1995-10-19
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRY-IN GEL 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 1995-10-19 under 510(k) number K954643. 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 TRY-IN GEL?

TRY-IN GEL is a medical device that received FDA 510(k) clearance on 1995-10-19. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K954643.

When did TRY-IN GEL receive FDA 510(k) clearance?

TRY-IN GEL received FDA 510(k) clearance on 1995-10-19, under 510(k) number K954643.

Who is the listed applicant for TRY-IN GEL?

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 TRY-IN GEL?

The FDA product code for TRY-IN GEL is EMA.

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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