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FDA 510(k)

SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM

K-Number: K884533 · 1989-04-12

ApplicantBlock Drug Company, Inc.
Decision Date1989-04-12
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Block Drug Company, Inc.. It received FDA 510(k) clearance on 1989-04-12 under 510(k) number K884533. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM?

SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-04-12. The listed applicant is Block Drug Company, Inc.. The 510(k) number is K884533.

When did SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM receive FDA 510(k) clearance?

SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM received FDA 510(k) clearance on 1989-04-12, under 510(k) number K884533.

Who is the listed applicant for SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM?

The FDA 510(k) record lists Block Drug Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM?

The FDA product code for SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM is KLE.

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Other records listing Block Drug Company, Inc. 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.

K945462SUPER POLI-GRIP DENTURE ADHESIVE CREAMK935925VISION PROPHY PASTE WITH FLUORIDEK933893VISION PROPHY PASTE WITHOUT FLUORIDEK881974PROFICIENT(TM) PROPHYLAXIS ANGLEK872225SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDERK862876NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM

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Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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