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FDA 510(k)

ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA

K-Number: K896657 · 1990-02-14

ApplicantPulpdent Corp.
Decision Date1990-02-14
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1990-02-14 under 510(k) number K896657. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA?

ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA is a medical device that received FDA 510(k) clearance on 1990-02-14. The listed applicant is Pulpdent Corp.. The 510(k) number is K896657.

When did ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA receive FDA 510(k) clearance?

ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA received FDA 510(k) clearance on 1990-02-14, under 510(k) number K896657.

Who is the listed applicant for ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA?

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 ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA?

The FDA product code for ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA is KIF.

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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: KIF)

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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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