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FDA 510(k)

PULPDENT GLASS IONOMER CEMENTS

K-Number: K952854 · 1995-07-14

ApplicantPulpdent Corp.
Decision Date1995-07-14
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT GLASS IONOMER CEMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K952854. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT GLASS IONOMER CEMENTS?

PULPDENT GLASS IONOMER CEMENTS is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Pulpdent Corp.. The 510(k) number is K952854.

When did PULPDENT GLASS IONOMER CEMENTS receive FDA 510(k) clearance?

PULPDENT GLASS IONOMER CEMENTS received FDA 510(k) clearance on 1995-07-14, under 510(k) number K952854.

Who is the listed applicant for PULPDENT GLASS IONOMER CEMENTS?

The FDA 510(k) record lists Pulpdent Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULPDENT GLASS IONOMER CEMENTS?

The FDA product code for PULPDENT GLASS IONOMER CEMENTS is DYH.

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Other records listing Pulpdent Corp. as applicant

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.

K014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTK014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEK020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMK014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEK013411PULPDENT CAVITY PREPARATION IVK994180PULPDENT CAVITY PREPARATION III

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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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