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FDA 510(k)

BOND-IT DUAL CURE ACTIVATOR

K-Number: K953859 · 1995-09-07

ApplicantJeneric/Pentron, Inc.
Decision Date1995-09-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BOND-IT DUAL CURE ACTIVATOR 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 1995-09-07 under 510(k) number K953859. 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 BOND-IT DUAL CURE ACTIVATOR?

BOND-IT DUAL CURE ACTIVATOR is a medical device that received FDA 510(k) clearance on 1995-09-07. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K953859.

When did BOND-IT DUAL CURE ACTIVATOR receive FDA 510(k) clearance?

BOND-IT DUAL CURE ACTIVATOR received FDA 510(k) clearance on 1995-09-07, under 510(k) number K953859.

Who is the listed applicant for BOND-IT DUAL CURE ACTIVATOR?

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 BOND-IT DUAL CURE ACTIVATOR?

The FDA product code for BOND-IT DUAL CURE ACTIVATOR 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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