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FDA 510(k)

PULPDENT ENDOPREP II

K-Number: K961089 · 1996-04-23

ApplicantPulpdent Corp.
Decision Date1996-04-23
Product CodeEKL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT ENDOPREP II is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1996-04-23 under 510(k) number K961089. The device is classified under product code EKL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT ENDOPREP II?

PULPDENT ENDOPREP II is a medical device that received FDA 510(k) clearance on 1996-04-23. The listed applicant is Pulpdent Corp.. The 510(k) number is K961089.

When did PULPDENT ENDOPREP II receive FDA 510(k) clearance?

PULPDENT ENDOPREP II received FDA 510(k) clearance on 1996-04-23, under 510(k) number K961089.

Who is the listed applicant for PULPDENT ENDOPREP II?

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 ENDOPREP II?

The FDA product code for PULPDENT ENDOPREP II is EKL.

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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

View all 78 devices →

Related Devices (Code: EKL)

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.

K992582PACIFIC IMPLANT TITANIUM ENDODONTIC POINTPacific Implant, Inc.K822568EAR PROBESKelleher Corp.

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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