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FDA 510(k)

S.S. WHITE-PENNWALT PRELUDE PIT SEALANT

K-Number: K801274 · 1980-06-09

ApplicantPennwalt Corp.
Decision Date1980-06-09
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S.S. WHITE-PENNWALT PRELUDE PIT SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Pennwalt Corp.. It received FDA 510(k) clearance on 1980-06-09 under 510(k) number K801274. 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 S.S. WHITE-PENNWALT PRELUDE PIT SEALANT?

S.S. WHITE-PENNWALT PRELUDE PIT SEALANT is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Pennwalt Corp.. The 510(k) number is K801274.

When did S.S. WHITE-PENNWALT PRELUDE PIT SEALANT receive FDA 510(k) clearance?

S.S. WHITE-PENNWALT PRELUDE PIT SEALANT received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801274.

Who is the listed applicant for S.S. WHITE-PENNWALT PRELUDE PIT SEALANT?

The FDA 510(k) record lists Pennwalt Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S.S. WHITE-PENNWALT PRELUDE PIT SEALANT?

The FDA product code for S.S. WHITE-PENNWALT PRELUDE PIT SEALANT is EBC.

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Other records listing Pennwalt 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.

K833241INTREXK801860S.S. WHITE-PENNWALT RENEW CALCIUM HYDROXK800133PANOREX II DENTAL X-RAY UNITK800063XR-710K780981PORTABLE PNEUMATIC CALIBRATOR 65-150

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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