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FDA 510(k)

PULPDENT SEAL RITE

K-Number: K911287 · 1991-06-10

ApplicantPulpdent Corp.
Decision Date1991-06-10
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT SEAL RITE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K911287. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT SEAL RITE?

PULPDENT SEAL RITE is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Pulpdent Corp.. The 510(k) number is K911287.

When did PULPDENT SEAL RITE receive FDA 510(k) clearance?

PULPDENT SEAL RITE received FDA 510(k) clearance on 1991-06-10, under 510(k) number K911287.

Who is the listed applicant for PULPDENT SEAL RITE?

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 SEAL RITE?

The FDA product code for PULPDENT SEAL RITE is EBC.

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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: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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