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FDA 510(k)

PULPDENT SODIUM HYPOCHLORITE SOLUTION

K-Number: K962743 · 1996-08-06

ApplicantPulpdent Corp.
Decision Date1996-08-06
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

PULPDENT SODIUM HYPOCHLORITE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1996-08-06 under 510(k) number K962743. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT SODIUM HYPOCHLORITE SOLUTION?

PULPDENT SODIUM HYPOCHLORITE SOLUTION is a medical device that received FDA 510(k) clearance on 1996-08-06. The listed applicant is Pulpdent Corp.. The 510(k) number is K962743.

When did PULPDENT SODIUM HYPOCHLORITE SOLUTION receive FDA 510(k) clearance?

PULPDENT SODIUM HYPOCHLORITE SOLUTION received FDA 510(k) clearance on 1996-08-06, under 510(k) number K962743.

Who is the listed applicant for PULPDENT SODIUM HYPOCHLORITE SOLUTION?

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 SODIUM HYPOCHLORITE SOLUTION?

The FDA product code for PULPDENT SODIUM HYPOCHLORITE SOLUTION is KJJ.

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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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Related Devices (Code: KJJ)

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.

K250279RC-SwiftPrepBelport Company, Inc., Gingi-PakK241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products

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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