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FDA 510(k)

BONDEX* GLASS IONOMER CEMENT

K-Number: K870211 · 1987-03-18

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1987-03-18
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONDEX* GLASS IONOMER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1987-03-18 under 510(k) number K870211. 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 BONDEX* GLASS IONOMER CEMENT?

BONDEX* GLASS IONOMER CEMENT is a medical device that received FDA 510(k) clearance on 1987-03-18. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K870211.

When did BONDEX* GLASS IONOMER CEMENT receive FDA 510(k) clearance?

BONDEX* GLASS IONOMER CEMENT received FDA 510(k) clearance on 1987-03-18, under 510(k) number K870211.

Who is the listed applicant for BONDEX* GLASS IONOMER CEMENT?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONDEX* GLASS IONOMER CEMENT?

The FDA product code for BONDEX* GLASS IONOMER CEMENT is EMA.

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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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