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FDA 510(k)

TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION

K-Number: K952240 · 1995-08-18

ApplicantJeneric/Pentron, Inc.
Decision Date1995-08-18
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1995-08-18 under 510(k) number K952240. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION?

TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K952240.

When did TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION receive FDA 510(k) clearance?

TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION received FDA 510(k) clearance on 1995-08-18, under 510(k) number K952240.

Who is the listed applicant for TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION?

The FDA 510(k) record lists Jeneric/Pentron, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION?

The FDA product code for TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION is EBC.

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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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