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FDA 510(k)

SELF ETCH BONDING PRIMER

K-Number: K003011 · 2000-11-28

ApplicantJeneric/Pentron, Inc.
Decision Date2000-11-28
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SELF ETCH BONDING PRIMER 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 2000-11-28 under 510(k) number K003011. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF ETCH BONDING PRIMER?

SELF ETCH BONDING PRIMER is a medical device that received FDA 510(k) clearance on 2000-11-28. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K003011.

When did SELF ETCH BONDING PRIMER receive FDA 510(k) clearance?

SELF ETCH BONDING PRIMER received FDA 510(k) clearance on 2000-11-28, under 510(k) number K003011.

Who is the listed applicant for SELF ETCH BONDING PRIMER?

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 SELF ETCH BONDING PRIMER?

The FDA product code for SELF ETCH BONDING PRIMER is KLE.

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Other records listing Jeneric/Pentron, Inc. as applicant

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Related Devices (Code: KLE)

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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