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FDA 510(k)

PULPDENT SEAL-RITE UDMA

K-Number: K963921 · 1996-11-12

ApplicantPulpdent Corp.
Decision Date1996-11-12
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT SEAL-RITE UDMA is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1996-11-12 under 510(k) number K963921. 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 UDMA?

PULPDENT SEAL-RITE UDMA is a medical device that received FDA 510(k) clearance on 1996-11-12. The listed applicant is Pulpdent Corp.. The 510(k) number is K963921.

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

PULPDENT SEAL-RITE UDMA received FDA 510(k) clearance on 1996-11-12, under 510(k) number K963921.

Who is the listed applicant for PULPDENT SEAL-RITE UDMA?

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 UDMA?

The FDA product code for PULPDENT SEAL-RITE UDMA 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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